Heart(y) news: clinical trial updates, Oct 29

October 29, 2010 by  
Filed under HEART AND STROKE

No firm conclusions about HDL cholesterol can be drawn from JUPITER sub-analysis
The JUPITER trial (Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin) investigated the efficacy of the anti-cholesterol drug rosuvastatin in preventing cardiovascular disease. Based on the JUPITER results, a paper has been published that claims that “a normal, healthy individual has level of low density lipoprotein (LDL), known as “bad cholesterol”, substantially lowered with a potent statin, then the level of HDL “good cholesterol” in that person no longer bears any relation to the remaining cardiovascular risk.”
However, the European Society of Cardiology (ESC) has expressed concerns about the paper’s claims and interpretations that might be easily misinterpreted as raising HDL levels having no beneficial cardiovascular effects.

RENEW: Intense diet/exercise improves weight, CV risk factors, in severely obese
More and more clinical trials on lifestyle-based interventions are being conducted. One such trial is the Re-Energize with Nutrition, Exercise and Weight Loss (RENEW) which studied the effect of intensive lifestyle interventions in the extremely obese. The results were very encouraging and will be discussed in detail in another post.

NIH blood pressure trial expands to include more older adults
The Systolic Blood Pressure Intervention Trial (SPRINT) trial is enrolling more elderly adults, e.g. an additional 1,750 study participants aged above 75. The trial is investigating how blood pressure range in is related to cardiovascular and kidney diseases, age-related cognitive decline, and dementia. According to Dr. Susan B. Shurin:

No large-scale clinical trial has examined the impact of aggressively lowering systolic blood pressure among older adults. The SPRINT study and the senior expansion address four of the 10 common causes of death and disability in adults over 75 years: heart disease, stroke, kidney failure, and dementia. The addition of these participants promises to provide useful scientific and public health information on a large and growing segment of the population.”

FDA stopped enrolment in TIDE trial
The enrolment for Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE) trial which compared the cardiovascular effects of long-term treatment with rosiglitazone vs. pioglitazone was stopped in July by the US FDA in connection with safety issues regarding rosiglitazone (Avandia). After postmarketing data review, European drug authorities suspended rosiglitazone from the EU market. In the US, Avandia remains but increased warnings.

Liraglutide in nondiabetics: Weight and BP improve at two years in extension trial
Finally, a drug-based trial with encouraging results. The diabetes drug liraglutide (Victoza) seems to be also effective as a weight loss drug in non-diabetic patients. Furthermore, it is helps in blood pressure control. However, liraglutide still has to overcome the hurdle of strict regulations on cardiovascular safety so that it doesn’t go the way of sibutramine.

Do commercial weight loss programs work? This one does.

October 12, 2010 by  
Filed under OBESITY

When it comes to branded weight loss plans, the name Jenny Craig is quite well-known. But do these programs work?

Now, health experts are generally skeptical of any commercially promoted weight loss programs. But researchers at the University of California in San Diego actually worked with Jenny Craig representatives on a clinical trial and have recently published their results. The research group, led by Dr. Cheryl Rock, emphasized that one of the conditions they set when they were approached by the company was “full control of the data, analysis, and publication of the diet study, with the sponsor [Jenny Craig] having just a “minimal” role in the trial design.”

The study participants consisted of 442 women chosen by the researchers and not rerouted as part of any Jenny Craig program. The women were randomly assigned to one of the following:

  • an in-person center-based program
  • a telephone-based counseling program
  • a control program

The participants in the first 2 (intervention) groups were provided by Jenny Craig, free of charge, the following:

  • prepackaged food items
  • diet plan
  • counseling
  • physical activity plans

The food provided was especially healthy, with very little sodium but lots of fruit and vegetables.

The participants received financial compensation when:

  • they come to follow-up appointments.
  • they achieve substantial weight loss within one year.
  • keep off most the lost weight for another year.

The results of the trial, as published in a paper by Rock and her group showed:

However, when considering only those patients with bad lipid profile at the start of the study, the interventions showed significant improvements during the 1st year of follow-up.

The results showed that this particular weight loss program does work. According to Dr William S Yancy of the VA Medical Center in Durham, NC:

“This shows that this particular program is effective for weight loss. There’s a low dropout rate; it’s a long-term study, which is important; and the weight loss was significant and substantial. It basically verifies that the Jenny Craig program works, compared with what might be typically offered to a person who is seeking weight loss.”

The questions to be considered now are:

How does this type of weight loss program compare with other commercial diets such as Weight Watchers for example?

Is it time to compared different commercial diets head to head?

Would it be more economically sensible (and more worthwhile investment in health care) for health insurance companies to pay for effective weight loss programs than say, bariatric surgery, and other obesity-related health problems?

Dr. Yancy adds:

“You certainly won’t get an argument from me. For a weight loss of 10 kg at one year and then 7 kg maintained a year later, that’s pretty substantial. Surgery is going to be more than that, especially the more advanced surgeries, but with the surgeries that are being done more and more that are less involved—gastric banding, for example—the weight loss is not much more than this. . . . It seems incongruous that you would pay for surgery but not for a behavioral or other type of program that is nearly as effective and that has side effects that are pretty much nil compared with surgery. And you’d have a tough time attributing any mortality to this kind of program.”

Interview with an Alzheimer’s expert, Part I: How far are we from a treatment?

September 9, 2010 by  
Filed under ALZHEIMER'S

5.3 million Americans have AD and 1 person every 70 seconds is diagnosed with the disease. There are many questions that need to be addressed regarding this disease.

We are pleased here at Battling for Health to have an exclusive interview with one of world’s foremost experts on Alzheimer’s disease (AD).

Dr. Michael Rafii, MD, PhD is the  co-director of the Memory Disorders Clinic at UCSD Perlman Ambulatory Care Center in La Jolla, California and Assistant Professor of Neurosciences at the University of California, San Diego. He is also the Associate Medical Core Director of the Alzheimer’s Disease Cooperative Study (ADCS) specializing in cognitive disorders, including dementias such as AD.

We sent several questions on AD to Dr. Rafii and we are happy to share with you his responses.

QUESTION: AD has been the subject of numerous research studies but till now, no effective treatment has been found. Why is it so difficult to find a treatment for this disease? How far are we from a treatment?

 ANSWER: Current research indicates that AD may in fact be silently developing in the brain over 10-20 years, BEFORE its key symptom of short term memory loss even shows up in patients.  The idea is that a protein called beta-amyloid is slowly accumulating in the brain, first damaging brain cells, and then depositing into plaques.  Many drugs, some of which target amyloid, have been tested in the symptomatic phase, which is likely too late in the course of the disease to have a tremendous impact.  However, we now have tools such as cerebrospinal fluid analysis and neuroimaging that allow us to measure amyloid in the brain, and are helping us detect AD’s pathology before symptoms show up.

 I think a good analogy for AD is heart diease.  If a patient presents with a Heart Attack, starting them on a cholesterol lowering medication at that time will be a little too late.  Rather, if they start lowering their cholesterol years earlier, they may never have the heart attack in the first place.  Some believe that amyloid is analogous to cholesterol.  The challenge is to measure the amyloid and to get drugs that lower amyloid INSIDE the brain.  By lowering amyloid levels, we might lower the risk of having symptomatic AD, that is memory loss and dementia.

 We currently have trials in progress for medications that are being evaluated in the mildest stage of AD, when memory loss is just starting to occur.  I am optimistic that in the next few years we will have new treatments available.

Medical research such those being conducted at Dr. Rafii’s clinic will hopefully bring AD treatment closer to reality. However, in order for research studies t be conducted, research subjects and volunteers are needed. Check out how you can help at: www.adcs.org/Studies/ImagineADNI.aspx.

 Follow Alzheimer’s Research on Facebook: www.facebook.com/pages/Alzheimers-Disease-Research/114211355284888

We have many more Q & A on AD with Dr. Rafii which we will share with you in the coming posts. Stay tuned!

It’s not all bad news for rosiglitazone

June 17, 2009 by  
Filed under DIABETES

capsuleRemember the controversy about the diabetic drug rosiglitazone (market name Avandia)? Remember the issues surrounding the APPROACH Trial – Assessment on the Prevention of Progression by Rosiglitazone on Atherosclerosis in Type 2 Diabetes Patients with Cardiovascular History? The drug was thought to increase cardiovascular risk, which brings to mind the problems faced by Vioxx.

Well, it seems that new trials indicate that it is not all bad news about rosiglitazone. In a late-breaking clinical trial using IVUS technology, rosiglitazone was compared with another diabetic drug glipizide. The trial’s primary endpoint, which is “a significant difference in percent atheroma, or plaque, buildup in coronary arteries“, was not met, but it did bring up some good points about rosiglitazone, especially with the secondary end points. The recent results show that:

IVUS stands for intravascular ultrasound and is the world’s largest study of diabetic patients with established coronary artery disease (CAD). The study involved 672 patients from 92 hospitals in 19 countries worldwide. The effect of diabetic drugs on the progression of CAD was assessed using the intravascular ultrasound technique. This was done by measuring the plaque burden using IVUS in a 40 mm segment of an atherosclerotic artery which hasn’t undergone any intervention because level of plaque build up was considered to be too low to require treatment.

People suffering from diabetes have increased risks for atherosclerosis, heart attack, stroke, and other cardiovascular disorders. Diabetes a metabolic disorder which interferes with blood sugar metabolism due to problems with insulin, the hormone produced by pancreas needed to metabolize glucose in the blood.

About the two drugs:

Rosiglitazone is a member of the thiazolidinedione class of diabetes drugs. It works by making the cells of the body more sensitive to insulin. In addition, the drug also has a positive impact on blood pressure, high density lipoprotein (HDL “good”) cholesterol and has anti-inflammatory properties. However, in 2007, the US FDA issued warnings about rosiglitazone increasing risk of cardiac events.

In a more recent report, the RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes) trial reports that rosiglitazone “does not increase overall cardiovascular risk.

Glipizide belongs to the sulfonylurea class of insulin secretagogues. It works by inducing the pancreas to secrete more insulin. It has been on the market for more than 40 years.

Photo credit: stock.xchng

Breast cancer vaccine in the making

February 2, 2009 by  
Filed under CANCER

Breast cancer is the most common cancer in women. In the US alone, it is estimated that 40,000 women will die from deadly disease this year. Mayo Clinic diagnoses and treats approximately 1,300 new breast cancer patients each year.

For the last 25 years, Mayo Clinic researcher Dr. Sandra Gendler has been studying a large molecule called MUC1 which is a naturally occurring protein. Her life’s work led to the development of a breast cancer vaccine. Dr. Gendler describes MUC1 as a protein that looks like a “bottle brush, covered with sugar”. These proteins are found on surfaces of cells in the lungs, breasts, stomach, intestine and reproductive tract. When cancer occurs, the cell architecture collapses and MUC1 with abnormal sugars are produced in abundant amount. These MUC1 proteins are found on more than 90% of breast cancers and are said to be involved in 70% of the breast cancer deaths of humans in 2007.

Dr. Gendler was the first scientist to clone MUC1 successfully by developing transgenic mice that produce human version of MUC1. She and her colleagues discovered that the production of MUC1 resulted in tumors in the mammary glands of these transgenic mice. This protein, however, can also act as an antigen and triggers weak immune response.

 Dr. Gendler and her team of researchers are now working together to develop a vaccine made of peptides based on MUC1 and HER2/neu, a molecule associated with 25% of breast cancers. These peptides were combined with adjuvants which can trigger immune responses and production of white blood cells. The preclinical studies showed that the vaccine can prevent tumor formation and slowed down the growth of existing tumors in mice.

 “The nice thing about MUC1’s being a target is that it is expressed in just about all breast cancers,” says Dr. Svetomir Markovic, a team member whose specialty is the development and clinical testing of cancer vaccines and immune boosting agents. “If this vaccine works, it will help most patients. Based on our laboratory data, this should work better than prior efforts.”

If this vaccine works in humans, this can be used with tamoxifen, an estrogen-based therapy which is commonly used as temporary post-treatment in preventing the recurrence of tumors. The vaccine, however, won’t be available anytime soon. Clinical research in general takes time.

According to Dr. Markovic

First, we need to see if the vaccine will produce an immune response. If it does, then we do another trial and ask whether that immune response will protect patients from cancer relapses. It will take at least five to seven years before we know.”

For breast cancer patients, that’s a very long time. But still we are crossing our fingers, if not for now but for generations of women to come.

Photo credit: stock.xchng

Cardiovascular studies are on the decline

November 18, 2008 by  
Filed under HEART AND STROKE

In the arena of drug development, cardiovascular medicine is no longer the favorite therapeutic area. This is according to a study published in the August issue of Nature, which analyzed the number of clinical trials registered at ClinicalTrials registery during the last two years, as reported by heartwire. Cardiology, which used to occupy the top priority position in research and development in the pharmaceutical industry, only now ranked 3rd. The top two places are occupied by cancer oncolgy and neurodegenerative medicine, respectively. This is despite the fact that lipid regulators which brought in US$ 35.2 billion worth of drug sales in 2006. The complete list of the six highest-ranked therapeutic/disease areas is given below:

  • Oncology
  • CNS disorders
  • Cardiology
  • Infectious diseases
  • Endocrinology
  • Respiratory diseases

The Nature review paper which surveyed Phase II to IV interventional studies sponsored by pharmaceutical companies and registered with the clinical-trials registry between October 2005 and September 2007 showed the same trend.

Does this mean that the incidence of cardiovascular diseases has decreased significantly that they are no longer a major health threat? Unfortunately, this is not the case. Many pharmaceutical companies feel that the profitable days of statins and beta-blockers are coming to an end as one drug after another, including the blockblusters Coreg and Lipitor, lost or will soon be losing its patent. With each drug going off patent, generic versions are already waiting at the sidelines to grab the market.

An as example of the lack of enthusiasm for cardiology, I reported in an earlier post about an internal memo from Pfizer which some how leaked which stated

“…an Integrated Strategic Plan (ISP) that focuses and prioritizes our R&D investments. Alzheimer’s Disease, Diabetes, Inflammation/Immunology, Oncology, Pain and Psychoses (Schizophrenia) are confirmed as our higher priority areas.

Several clinical phase drugs which showed blockbuster potential fell short of expectations and many are facing safety issues. Results from the ENHANCE trial which tested ezetimbe (Zetia) in combination simvastatin were disappointing as well as controversial. More recently, all clinical development programs of rimonabant (Acomplia), earlier thought to be the next bestseller, were halted when the European Medicines Agency (EMEA) announced that “it had asked the company [sanofi-aventis] to suspend marketing of the drug, on the grounds that its benefits no longer seemed to outweigh its risks.” The APPROACH study failed to show that rosiglitazone (Avandia) prevents atherosclerosis progression in diabetes patients, thus probably putting a stop to the drug’s use in cardiovascular medicine. Late last year, the US FDA added a black box warning to Avandia’s label due to increased heart attack risks.

As previously discussed in a previous post, maybe it’s time to look more towards lifestyle change strategies for prevention and treatment of cardiovascular treatment. And I think it’s worth repeating some practical tips here:

Photo credit: stock.xchng

Diabetes Clinical Trial Update

October 2, 2008 by  
Filed under DIABETES

Before we review what’s going on in diabetes clinical trials let’s review the basics of clinical trials for our new readers.

What is a clinical trial?

A clinical trial is scientific research involving people that studies the effects of a new medication, therapy or device to determine if it is safe and effective.

In the United States, clinical trials are monitored by the Food and Drug Administration.

The Phases of a Clinical Trial:

Phase I evaluates dosage parameters.

Phase II continues to evaluate safety and begins to study efficacy.

Phase III compares the new drug with standards of care or if there are none, a placebo.

Phase IV is used if the drug normally used as a standard is to be used for another condition or if the formulation is changed. This phase may also be used for extended studies on drug side effects.

Diabetes clinical trials may involve studies of prevention of diabetes or the treatment of diabetes.

Types of Diabetes Clinical Trials

  • Action studies (doing something) – These focus on finding out whether actions people take, such as exercising more or quitting smoking, can prevent diabetes or their impact on current diabetics.
  • Agent studies (taking something) – These studies examine whether taking certain medicines, vitamins or food supplements (or a combination) have an affect on preventing or treating diabetes.

Why Participate in a Clinical Trial?

People participate in clinical trials for many reasons including the opportunity to try new cutting edge therapies under the care of leading researchers and health care providers, and for the opportunity to contribute to research to help themselves and others.

Clinical trials do have side effects including the possible negative effect of the therapies and/or no effects at all and they can be more time consuming than originally anticipated.

If you are considering participating in a clinical trial not only is it important to explore all facets of the trials through informed consent, but it is important to determine the cost and funding of a clinical trial and how your insurance coverage or Medicare comes into play. While often the medication being tested is free, there may be additional costs such as lab tests and hospitalization which are not.

Get answers ahead of time.

In depth resources on clinical trials and registries for clinical trials:

ClinicalTrials.gov not only lists registries of current clinical trials in the U.S and other countries but breaks them down according to condition, drug, sponsor and location.

World Health Organization International Clinical Trials Registry Platform. “The mission of the WHO Registry Platform is to ensure that a complete view of research is accessible to all those involved in health care decision making.”

CRISP, Computer Retrieval of Information on Scientific Projects. “A biomedical database system containing information on research projects and programs supported by the Dept. of Health and Human Services.”

Center Watch: Clinical Trials Listing Service. This site provides a notification services for new clinical trials.

American Diabetes Association provides basic information on clinical trials.

Juvenile Diabetes Research Foundation International lists current JDRF funded clinical studies and provides information on what phase those studies are currently in.

The Children With Diabetes site lists current clinical trials.

Read more

In the making: a vaccine against hypertension

September 18, 2008 by  
Filed under HEART AND STROKE

You’ve heard of vaccines against polio, measles, small pox. What about a vaccine against hypertension? Last year, a paper presented at the American Heart Association Scientific Sessions reported about an investigational vaccine against angiotensin II. Angiotensin II is a vasoconstrictor agent – it causes constriction of blood vessels leading to increase in blood pressure. When a vaccine is investigational, it is still being tested and not yet ready for use.

However, this vaccine being tested by Cytos Biotechnology seems to be promising.

The name of the vaccine is CYT006-AngQb and is a virus-like particle-based conjugate vaccine. The vaccine is now tested in Phase II clinical trials. This means that the vaccine has passed through tests with animals and healthy humans without major safety problems. In Phase II trials, medications are tested in people showing the symptoms for which the drugs are indicated. In this case, CYT006-AngQb is intended for patients with mild to moderate hypertension.

Is the vaccine effective?

Preliminary results of the 2007 tests show that

“treatment with the high dose produced a significant reduction of daytime ambulatory blood pressure [BP] and a marked reduction in the early morning hours, when most adverse cardiovascular events occur.”

If approved, what would be the advantage of the vaccine over currently available antihypertensive drugs?

Well, antihypertensive drugs have to be taken on a daily basis because of their short half-life. CYT006-AngQb, on the other hand, produces extended antibody response because it has a half-life of about 4 months. That means, a hypertensive patient only needs to take medication 3 to 4 times a year.  In addition, currently available hypertensive drugs are not so effective in controlling early morning increases in blood pressure, the time of the day when major cardiac events such as heart attacks and stroke usually occur.

Even if the vaccine proves to be effective, will it be safe?

The study tested the vaccine in 72 patients with mild to moderate hypertension and followed-for 12 moths. During this period, the vaccine was observed to be well-tolerated by the study participants. There were side effects but they were mostly mild and the most common of these were headaches and irritation on the injection site.

The author, Prof. Juerg Nussberger

“Despite the fact that effective drugs are available to treat hypertension, only about one out of four hypertensive patients has the blood pressure successfully controlled. Once people are aware of the often symptomless hypertension, they have to take their medications daily, and many are apparently unable or unwilling to take pills every day for the rest of their lives. The major remaining medical need in this important therapeutic area is thus improved patient compliance. If we could support or substitute the oral therapy with a vaccine that would need to be given just every few months, I think we could achieve a better control of high blood pressure.”

The results of the study were later published in the journal Lancet.

Photo credit: syringe by Scyza at Stock.xchng

Qnexa

August 6, 2008 by  
Filed under DIABETES

Qnexa is a new drug targeted at diabetes from VIVUS, currently undergoing clinical trials.

Basically Qnexa is combination of phentermine and an epilepsy drug Topamax (also used for migraines) .

From the VIVUS site:

“Qnexa is a proprietary therapeutic formulation and dosing regime that incorporates the active ingredients from two previously approved products with demonstrated weight loss properties. By combining the activity of each of these compounds, Qnexa simultaneously addresses appetite and satiety, the two main mechanisms that impact eating behavior. ”

July 1, VIVUS announced positive results from their Phase II Clinical Trials with Qnexa. “A subset analysis of subjects with higher cardiovascular risk factors at baseline had significantly greater improvements on Qnexa as compared to placebo.” Source: Medical News Today.

August 4, 2008 Vivus released their 2Q Earnings, and VIVUS President and CEO, Leland Wilson said regarding the results of the Phase II Clinical Trial or the OB-202 study, “The primary endpoint of this trial was a reduction in hemoglobin A1c. Subjects on Qnexa achieved a reduction in A1c of 1.2%. Importantly, Qnexa patients also achieved an average weight loss of 8%, an improvement in their cardiovascular risk factors, namely blood pressure, triglycerides, and weight circumference.

We believe Qnexa is the first oral diabetic medication to significantly lower blood sugar, weight and cardiovascular risk.”

More on the Qnexa trial: The Qnexa trial involved 200 subjects, 159 women and 41 men with an average age of 40 and a mean body mass index (BMI) of 38. Each subject in the study received daily doses, consisting of Qnexa, placebo, or each one of the active ingredients separately. Subjects were asked to reduce caloric intake by 500 calories per day. The most common adverse effects reported were nausea, paresthesias, constipation, dry mouth and dizziness.

What’s next for Qnexa?

Phase II Clinical Trials.

VIVUS will meet with the FDA later this year to discuss the details of a Phase III development program for diabetes.

All Qnexa Phase III Clinical Trials are fully enrolled and are progressing. Data from the OB-301 study is expected to be available by the end of 2008, and data from the OB-302 and 303, the one year studies are expected to be available by mid-2009.

The Resveratrol Link

July 16, 2008 by  
Filed under CANCER

Considering a wine to compliment tonight’s meal?

Think red.

Think resveratrol.

Resveratrol is a compound that is found naturally in wines, blueberries and peanuts. The largest amount can be found in the skin of the red grape and in red wines which are fermented in the skin of the grape.

Resveratrol has been in the news over the last few years as studies show a connection between the compound and its cardiovascular and anti-aging properties.

While the resveratrol has been recognized as a powerful antioxidant, it is now getting a second glance as a link to preventing breast cancer. Researchers have recently made the connection between resveratrol and reducing breast cancer risks.

From the July, Cancer Prevention Research, comes this news:

“Resveratrol has the ability to prevent the first step that occurs when estrogen starts the process that leads to cancer by blocking the formation of the estrogen DNA adducts. We believe that this could stop the whole progression that leads to breast cancer down the road,” study author Eleanor G. Rogan, a professor in the Eppley Institute for Research in Cancer and Allied Diseases at the University of Nebraska Medical Center, said in a prepared statement.”

Source:Atlanta Journal Constitution

ScienceDaily last year reported a link between resveratrol and prostate cancer in a clinical study out of the University of Alabama at Birmingham. “In the study resveratrol-fed mice showed an 87 percent reduction in their risk of developing prostate tumors that contained the worst kind of cancer-staging diagnosis. The mice that proved to have the highest cancer-protection effect earned it after seven months of consuming resveratrol in a powdered formula mixed with their food. ”

The next step for resveratrol will be clinical studies in humans.

Read more

Diabetes Clinical Trial Update

July 9, 2008 by  
Filed under DIABETES

Time for an update on what’s new in the area of diabetic clinical trials.

A clinical trial is scientific research involving people that studies the effects of a new medication, therapy or device to determine if it is safe and effective.

For more information on what a clinical trial is, see the Battling Diabetes archives on clinical trials.

Currently enrolling clinical trials of interest to diabetics:

The University of California at San Francisco, Diabetes Center is currently enrolling patients in five studies of people with type 1 and type 2 diabetes, and three related studies of non-diabetics. Two of particular interest are:

Non-Diabetics: Alpha Lipoic Acid and Insulin Resistance — In this study, which is seeking volunteers 20 to 60 years of age, researchers wish to see if the antioxidant Alpha Lipoic Acid (LA) will improve insulin sensitivity in healthy, non-diabetic volunteers. See the Battling Diabetes article on ALA in the archives.

Non-Diabetics: Chromium and Insulin Resistance — This study is seeking volunteers 20 to 50 years of age with normal body weight who are not exercising regularly. Researchers want to find out the effect of chromium therapy on insulin resistance and will test all study subjects to determine if they are insulin-resistant or insulin-sensitive. See the Battling Diabetes article on chromium in the archives.

Currently the New Mexico ACT Trials (Albuquerque Clinical Trials) are recruiting Type Two Diabetics. Two of particular interest are sponsored by GlaxoSmithKline and are intended to study and compare the effects of two medications, one new and one already approved, in lowering high blood sugars, lowering lipids, and lowering body weight in patients who use diet and exercise only to control their type II diabetes.

A third of interest is sponsored by Bristol Myers Squibb and involves a new compound combination with Metformin and/or TZD and/or Insulin therapy. Now enrolling patients ages 18-77 with the intention of assessing the effects of lowering blood sugars by management of diabetic medications.

In the News!

Forbes.com, July 3, 2008. The Great Drug Debate. A panel of FDA experts voted 14-2 on Wednesday that diabetes drugs should face far more scrutiny to be sure they don’t cause heart attacks. The doctors present agreed the drugs should be tested for several years in 2,000 diabetics without heart disease before being approved.

Read more

Turmeric for Diabetes

July 1, 2008 by  
Filed under DIABETES

turmeric.jpgFamiliar with turmeric?

Turmeric is a spice in the ginger family.

Spelled t-u-r-m-e-r-i-c, it is pronounced tumeric.

Turmeric is the primary ingredient in curry powder and also gives mustard its yellow color. Curcumin is the main property of turmeric.

Long hailed for its antioxidant properties, turmeric is thought to heal sores, cure arthritis and is considered an anti-Alzheimer’s agent. Curcumin is currently under investigation for its anti-cancer and anti-inflammatory effects at M.D. Anderson Cancer Center.

The Linus Pauling Institute at Oregon State University has completed studies which show promising results for the use of curcumin supplementation for colorectal cancer and Alzheimer’s.

The National Center for Complementary and Alternative Medicine (NCCAM), a division of the National Institutes of Health states:

  • Turmeric is considered safe for most adults.
  • High doses or long-term use of turmeric may cause indigestion.
  • In animals, high doses of turmeric have caused liver problems. No cases of liver problems have been reported in people.
  • People with gallbladder disease should avoid using turmeric as a dietary supplement as it may worsen the condition.
  • But what about diabetes?

    Drew Tortoriello, M.D., an endocrinologist and research scientist at the Naomi Berrie Diabetes Center at Columbia University Medical Center, and his team are studying the effects of turmeric on laboratory mice and the diabetes connection. They have discovered that turmeric fed obese mice are less likely to develop Type 2 Diabetes and had less inflammation of fat tissues and liver compared to the control group.

    What’s the connection? They suspect the anti-inflammatory, antioxidant properties of the spice reduces insulin resistance, inflammation and reduces some body weight.

    What does this mean for diabetics?

    Eat more curry?

    “It’s too early to tell whether increasing dietary curcumin [through turmeric] intake in obese people with diabetes will show a similar benefit,” Dr. Tortoriello said. “Although the daily intake of curcumin one might have to consume as a primary diabetes treatment is likely impractical, it is entirely possible that lower dosages of curcumin could nicely complement our traditional therapies as a natural and safe treatment.”

    Source:Medical News Today.

    Interested in reading more about turmeric and clinical science?

    Check out tumeric-curcumin . com

    In the meantime a few turmeric/curry dishes for diabetics:

    From the American Diabetes Association, Virtual Grocery Store: Curried Shrimp

    From Bella Online, Cauliflower with Turmeric

    And dLife has a great Bombay Curry recipe.

    Cancer Immunity?

    June 30, 2008 by  
    Filed under CANCER

    mouse.jpgThe FDA has given approval for a clinical trial that is all about cancer immunity. Wake Forest University School of Medicine, in Winston-Salem, North Carolina is the site of this amazing cancer research. Dr. Zheng Cui, an associate professor at the university, who teaches biochemistry, molecular biology, lipid biochemistry, cancer biology, and cancer immunology and his team will lead the trial.

    The trial began with the accidental discovery of a mouse that was resistant to cancer. Repeated injection of cancer cells yielded zero tumor growth. Breeding the cancer immune mouse resulted in three of the seven grandchildren of the immune mouse also having the same immune characteristics.

    The key to the mystery apparently lies in the white blood cells of the immune resistant mice.

    The follow-up phase involved transfusing tumor ridden mice with white blood cells from the immune resistant mice. The amazing result was a cure of cancer in the tumored mice.

    The next postulate: are there cancer immune humans? What about families where generations show zero cancer? The researchers will begin searching for these “cancer immune” humans. After testing, the white blood cells will be transfused into cancer patients. This process is obviously not new and is similar to a blood transfusion. The result is a bolstered immune system that is immune to cancer.

    In the recent issue of the New Scientist, Dr. Cui states that “nearly 97 percent of the cancer cells exposed to certain donor immune cells were killed, while in other cases the kill ratio dropped to as low as two percent. Immune cells from patients over the age of 50 were weaker than others while stress and the time of year also appeared to factor into the efficacy rate. One potential threat to his experiment will be graft-vs-host disease. ”

    Dr. Cui says, “We’ve minimized all the risk, especially for these first few rounds of trials,” he said. “We don’t know what will happen, but we hope this will cure several types of cancer and help a few people in the next months. This could be another arrow in the cancer treatment quiver.”

    Check out this YouTube video on the story.

    Read the full story at the News Observer or the UK Telegraph.
    You can also check out this interview with Dr. Cui at the Speculist.

    Chocolate For Cancer?

    June 25, 2008 by  
    Filed under CANCER

    chocolate.jpgThat’s right. Chocolate for cancer.

    This story certainly perked up my ears.

    A recent study from Georgetown University has shown that the same cocoa beans used to make chocolate have a chemical which kills tumors in the laboratory setting. Specifically they are using synthetic procyanidins, a class of flavanols. We have discussed the anti-oxidant property of flavanols on Battling Cancer .

    Flavonoids: Found in brewed tea. Flavonoids are also found in dark chocolate. An interesting clinical trial on dark chocolate is found on WebMD. Studies are now showing the impact on flavonoids in various types of cancer, such as prostrate and ovarian cancer as noted at ScienceDaily.

    The synthetic flavanols known as GECGC, are patented by the Mars Company. Yes, the same company that makes Mars bars.

    The testing utilized amounts of flavanols that a person might eat or use.

    The study’s lead author, Min Kim said” “Overall, GECGC showed the most effect in treating cancer cells that are normally fast growing. And in fact it demonstrated the most killing power in colon cancer that suggests the chemical could serve as a promising therapeutic for colon cancer.”

    Source: The Times of India

    Diabetes Clinical Trials

    June 9, 2008 by  
    Filed under DIABETES

    j0409545.jpgWhat is a clinical trial?

    A clinical trial is scientific research involving people that studies the effects of a new medication, therapy or device to determine if it is safe and effective.

    In the United States, clinical trials are monitored by the Food and Drug Administration.

    The Phases of a Clinical Trial:

    Phase I evaluates dosage parameters.

    Phase II continues to evaluate safety and begins to study efficacy.

    Phase III compares the new drug with standards of care or if there are none, a placebo.

    Phase IV is used if the drug normally used as a standard is to be used for another condition or if the formulation is changed. This phase may also be used for extended studies on drug side effects.

    Diabetes clinical trials may involve studies of prevention of diabetes or the treatment of diabetes.

    Types of Diabetes Clinical Trials

    • Action studies (doing something) – These focus on finding out whether actions people take, such as exercising more or quitting smoking, can prevent diabetes or their impact on current diabetics.
    • Agent studies (taking something) – These studies examine whether taking certain medicines, vitamins or food supplements (or a combination) have an affect on preventing or treating diabetes.

    Why Participate in a Clinical Trial?

    People participate in clinical trials for many reasons including the opportunity to try new cutting edge therapies under the care of leading researchers and health care providers, and for the opportunity to contribute to research to help themselves and others.

    Clinical trials do have side effects including the possible negative effect of the therapies and/or no effects at all and they can be more time consuming than originally anticipated.

    If you are considering participating in a clinical trial not only is it important to explore all facets of the trials through informed consent, but it is important to determine the cost and funding of a clinical trial and how your insurance coverage or Medicare comes into play. While often the medication being tested is free, there may be additional costs such as lab tests and hospitalization which are not.

    Get answers ahead of time.

    In depth resources on clinical trials and registries for clinical trials:

    ClinicalTrials.gov not only lists registries of current clinical trials in the U.S and other countries but breaks them down according to condition, drug, sponsor and location.

    World Health Organization International Clinical Trials Registry Platform. “The mission of the WHO Registry Platform is to ensure that a complete view of research is accessible to all those involved in health care decision making.”

    CRISP, Computer Retrieval of Information on Scientific Projects. “A biomedical database system containing information on research projects and programs supported by the Dept. of Health and Human Services.”

    Center Watch: Clinical Trials Listing Service. This site provides a notification services for new clinical trials.

    American Diabetes Association provides basic information on clinical trials.

    Juvenile Diabetes Research Foundation International lists current JDRF funded clinical studies and provides information on what phase those studies are currently in.

    The Children With Diabetes site lists current clinical trials.

    Diabetic Clinical Trials in the News:

    • The TODAY Study. (Treatment Options for Type 2 Diabetes in Adolescents and Youth) “The purpose of this trial is to examine the safety and effectiveness of three different treatments for type 2 diabetes in the pediatric population. The TODAY trial is being conducted at 12 medical centers around the United States. ” The is an open trial that is actively recruiting participants.
    • TrialNet. “TrialNet is a network of 18 Clinical Centers working in cooperation with screening sites throughout the United States, Canada, Finland, United Kingdom, Italy, Germany, Australia, and New Zealand. This network is dedicated to the study, prevention, and early treatment of type 1 diabetes. ” TrialNet has many clinical trials going on in various stages. The newest studies, which are recruiting participants, are the Diabetes Interventions Study and the Natural History Study, and The Oral Insulin Study.
    • Closing The Loop in Type 1 Diabetes. Currently recruiting for this study at Mass. General Hospital. ” Researchers at the MGH Diabetes Research Center are recruiting subjects to test an Automated Closed-Loop Glucose Control System for Type I Diabetics.”

    Battling Books:

    Applying The Evidence: Clinical Trials in Diabetes by Anthony Barnett. (2005)
    forefront.jpgForefront, the American Diabetes Association’s research magazine featuring profiles of cutting-edge ADA-funded research currently taking place throughout the nation.”

    Clinical Trial Update

    April 29, 2008 by  
    Filed under CANCER

    bluetesttube.jpgNow that you understand clinical trials, let’s see what new cancer initiatives are in progress right now.

    Clinical Study Results.org is an excellent site for finding out what is going on with drug company research and provides clinical study results in a “reader friendly standardized format” to make the results for many marketed pharmaceuticals more transparent. ”

    Now Recruiting:

    • The A.I.M.M Trial. A Phase 3 clinical study for Allovectin-7. “The purpose of the A.I.M.M. Trial is to find out whether Allovectin-7® works better than standard chemotherapy for people with Stage 3 or Stage 4 melanoma.” Per the NCI site, “Allovectin -7 is a substance that is being studied as a gene therapy in the treatment of cancer. It increases the ability of the immune system to recognize cancer cells and kill them.
    • OVATURE (Ovarian Tumor Response) A research opportunity for women with recurrent ovarian cancer. ” Patients in the trial will receive an experimental treatment regimen consisting of weekly carboplatin. Half of the patients in the trial will also receive the investigational drug phenoxodiol. The other half will receive a placebo so that neither researchers nor patients can tell which arm of the trial the patient is in.” See the Novogen site for more information on phenoxodiol known as multiple signal transduction regulators (MSTRs).
    • The SPRAY Study. A study of Sativex for pain relief in patients with advanced malignancy. The Phase II trial is currently recruiting patients. “The purpose of this study is to determine the effective dose range and to demonstrate a non-effective dose range of Sativex in patients with advanced cancer, who experience inadequate pain relief even though they are on optimized chronic opioid therapy.” For more information see the Center Watch, Clinical Trials Listing Service site.

    News:

    April 15, 2008 the National Cancer Institute posts the positive results of a five year study of adenoma prevention with Celecoxib. Celecoxib Reduces Risk of Precancerous Colorectal Polyps: Five-Year Results of APC Trial.

    ScienceDaily, April 8, 2008. Randomized Clinical Trial Results on Preoperative Chemotherapy in Early Breast Cancer. “Eight cycles of preoperative chemotherapy was no better than six cycles in women with early breast cancer who had responded to two initial cycles, according to data from a randomized controlled trial.”

    Battling Books:

    Informed Consent: The Consumer’s Guide to the Risks and Benefits of Volunteering for Clinical Trials by Deborah Borfitz (2002)

    Surviving Terminal Cancer: Clinical Trials, Drug Cocktails and Other Treatments Your Oncologist Won’t Tell You About by Ben A. Williams. (2002)

    What’s an Antioxidant?

    April 24, 2008 by  
    Filed under CANCER

    fork.jpgWhat exactly is an antioxidant and what does it have to do with cancer?

    Per the American Dietetic Association: “Antioxidants are dietary substances including some nutrients such as beta carotene, vitamins C and E and selenium, that can prevent damage to your body cells or repair damage that has been done.”

    Basically an antioxidant is capable of counteracting the normal damaging effects of oxidation by neutralizing free radicals in the body. The balance of antioxidants to oxidants is disturbed by poor diet, smoking, disease, normal aging, x-rays and many other things. When an antioxidant neutralizes a free radical, the antioxidant becomes oxidized and the body needs to be resupplied with antioxidants.

    From the U.S. Department of Agriculture: “Antioxidants such as vitamins A, C and E, help protect healthy cells from damage by free radicals. Normal body functions such as breathing or physical activity, and other lifestyle habits, such as smoking, produce substances called free radicals that weaken healthy cells. Weakened cells are more susceptible to cardiovascular disease and certain types of cancer.”

    It’s important to remember that the consumption of exceptionally large amounts of antioxidants can be harmful to the body. Current studies in antioxidants are constantly reevaluating levels of antioxidants needed for optimal health and for healing. Antioxidants are found in foods we eat; however if you are interested in oral supplements consult your physician. As a report of the American Cancer Society points out, the effect of supplements on cancer tumors and interactions with medication leaves many still unanswered questions. Talk to your physician. The National Cancer Institute provides information on antioxidants under investigation in clinical trials.

    Traditional antioxidants:

    Vitamin C: Red pepper, yellow pepper, strawberries, oranges lemons, cantaloupes, cauliflower. Information on the connection to vitamin C and cancer is provided at the Linus Pauling Institute.

    Vitamin E: Prevents the oxidation of fat and Vitamin A. It is thought to prevent prostrate and breast cancer. Sources of vitamin E include nuts, avocados, mangoes and sweet potatoes. See the National Cancer Institute site for information on the SELECT trial, (Selenium and Vitamin E trial) which studied the effect of these supplements on prostate cancer.

    Beta carotene:Found naturally in foods such as cantaloupe, mangoes, papaya, pumpkin, peppers, spinach, kale, squash, sweet potatoes, and apricots. Note that the results of a clinical trial showed that beta carotene supplements should be avoided by smokers. See the National Cancer Institute for more information.

    Selenium: Naturally found in seafood, beef, pork, chicken, Brazil nuts, brown rice, and whole wheat bread. Selenium studies show its importance in fighting prostate cancer, per a study by the University of Arizona Cancer Center.

    Antioxidants Being Studied:

    Flavonoids: Found in brewed tea. Flavonoids are also found in dark chocolate. An interesting clinical trial on dark chocolate is found on WebMD. Studies are now showing the impact on flavonoids in various types of cancer, such as prostrate and ovarian cancer as noted at ScienceDaily.

    Lycopene: Found in tomatoes, watermelon and pink grapefruit. For more information on lycopene and cancer see the Mayo Clinic site or Lycopene and Health.

    Phytochemicals: Found in blueberries, strawberries and cranberries, phytochemicals are now linked to a positive impact on certain cancers such as colon cancer and liver cancer. The Daily Mail, shares a recent study at Rutgers University on blueberries. NutraUSA shares a similar study with promise for liver cancer.

    Recommended daily amounts of vitamins, and minerals are available from the U.S. Department of Agriculture library. They include a series of reports “on the dietary reference values for the intake of nutrients by Americans and Canadians.”

    Battling Books:

    The Super Antioxidant Diet and Nutrition Guide: a Health Plan for the Body, Mind and Spirit by Robin Jeep, Richard B. Couey, and Sherie Ellington Pitman (February 2008)

    Antioxidants Against Cancer by Ralph W. Moss (2000)

    Additional information is available in our archives:

    The Relationship Between Cancer and Antioxidants

    A Clinical Trials Primer

    April 2, 2008 by  
    Filed under CANCER

    Basically a clinical trial is a scientific research involving people, that studies the effects of a new medication, therapy or device to determine if it is safe and effective.

    In the United States, clinical trials are monitored by the Food and Drug Administration.

    The Phases of a Clinical Trial:

    Phase I evaluates dosage parameters.

    Phase II continues to evaluate safety and begins to study efficacy.

    Phase III compares the new drug with standards of care or if there are none, a placebo.

    Phase IV is used if the drug normally used as a standard is to be used for another condition or if the formulation is changed. This phase may also be used for extended studies on drug side effects.

    Read more

    Related Posts with Thumbnails

    NOTE: The contents in this blog are for informational purposes only, and should not be construed as medical advice, diagnosis, treatment or a substitute for professional care. Always seek the advice of your physician or other qualified health professional before making changes to any existing treatment or program. Some of the information presented in this blog may already be out of date.