Diabetes Clinical Trials Ignore Heart Disease Risks

| May 9, 2013

Cardiovascular complications, including heart disease and stroke, are the biggest worry for anybody who suffers from diabetes. And the amount of research being carried out into diabetes worldwide is staggering, amounting to thousands of research studies every year. So, you might think that the result of all this effort would be some real breakthroughs in reducing heart disease risks. But, as a recent review discovered, the vast majority of diabetes research fails to address the real issues affecting patients.

The new review forms part of a joint initiative by the US Food and Drug Administration (FDA) and Duke University in North Carolina, to promote better clinical trials. What it revealed, after examining almost 2500 recent, diabetes-related studies, is disturbing. For a start, three quarters of these studies looked at treatments, most of which were drugs, and only one study in ten was concerned with preventive measures. Just 1.4 per cent looked at cardiovascular outcomes such as heart disease risk. And, perhaps not surprisingly, a massive 78 per cent of all trials involved Big Pharma funding.

Most clinical trials excluded elderly people and children, even though these are the groups in which diabetes is most difficult to manage. Also, most of the trials involved small numbers of participants, were of short duration and did not address longer term outcomes, in particular cardiovascular complications. The researchers concluded that “recent diabetes trials may not sufficiently address important diabetes care issues or involve affected populations”.

Rather than getting to the bottom of a serious and complex health problem and resulting in better care for patients, the sole purpose of most diabetes research is to sell more drugs for the pharmaceutical industry. Doctors want to see positive results from randomised, placebo-controlled trials before prescribing a particular diabetes drug. The industry ensures that plenty of such trials (with the right results) are published. They just don’t want to complicate them by including “difficult” patient groups or by doing large or long-term studies that could show up adverse side effects.

When it comes to side effects, diabetes drugs don’t score well. As I pointed out in The Real Diabetes Truth on 28 March 2013, since Avandia was banned in 2010 after being found to increase the risk of heart attacks, six other diabetes drugs have been linked to deadly or dangerous health problems. So, it is little wonder that the drugs companies are not keen on long-term trials or on including those patient groups that may be more susceptible to side effects.

What you can do to reduce the risk of heart disease

So, if all of those earnest researchers in white coats are not doing much to improve your risk of heart disease and other cardiovascular complications, what can you do for yourself? Here are my top recommendations for avoiding heart disease or stroke, particularly if you have diabetes or metabolic syndrome.

• Avoid sugar and eat a low GL diet. Eating in a way that keeps blood sugar levels low really is the most important thing you can do.

• Get regular exercise. Moving your body reduces blood sugar levels, lowers blood pressure and improves your blood fat profile, all things that reduce heart disease risks.

• Don’t sit for too long. Irrespective of how often you exercise, the amount of time spent sitting raises cardiovascular risks. Take regular breaks from the computer, TV or whatever else is keeping you glued to your seat.

• Take a supplement of alpha-lipoic acid (ALA). Evidence from animal experiments suggests that it may help to protect against diabetic heart disease. You can read more about ALA in my post for The Real Diabetes Truth on 30 July 2012.

• Eat oily fish, walnuts and linseeds, to get the heart-healthy benefits of the omega-3 fatty acids they contain. A meta-analysis of 16 human clinical trials has concluded that these “good” fats make a big difference to the health of your arteries and could help prevent heart disease.

• If your blood pressure is too high (a major risk factor for heart disease), use natural means to reduce it. Berberine (see The Real Diabetes Truth 4 April 2013), garlic and a Chinese herbal combination called Alistrol are all safe and effective for this.

• Take at least 2000 IU of vitamin D a day. Most of the UK population is deficient in this vital nutrient, which recent research has shown works in several different ways to reduce heart disease risks.

Statins are a group of cholesterol-lowering drugs that are at the front line of conventional treatment to reduce heart disease risk. A major problem with statins, though, is that they also raise the risk of diabetes. New research has shown that the anti-oxidant CoQ10 can reduce this side effect of statins. I shall be looking further at statins, diabetes and CoQ10 in my next blog post.

Wishing you the best of health,

Martin Hum
PhD DHD Nutritionist
for Real Diabetes Truth

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Bear in mind we are not addressing anyone’s personal situation and you should rely on this for informational purposes only. Please consult with your own physician before acting on any recommendations contained herein.


1. Lakey WC, Barnard K, Batch BC, Chiswell K, Tasneem A, Green JB. Are current clinical trials in diabetes addressing important issues in diabetes care? Diabetologia. 2013 Apr 8. [Epub ahead of print]

2. Li CJ, Lv L, Li H, Yu DM. Cardiac fibrosis and dysfunction in experimental diabetic cardiomyopathy are ameliorated by alpha-lipoic acid. Cardiovasc Diabetol. 2012; 11:73.

3. Wang Q, Liang X, Wang L, Lu X, Huang J, Cao J, Li H, Gu D. Effect of omega-3 fatty acids supplementation on endothelial function: a meta-analysis of randomized controlled trials. Atherosclerosis. 2012; 221(2):536-543.

4. Keogh JB, Clifton PM. Vitamin D and cardiovascular health. Curr Opin Lipidol. 2013; 24(2):183-184.

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