UTHCT participating in major clinical study of drug that may prevent diabetes

Wednesday, October 25, 2006

Every 24 hours, 4,100 people in the United States are diagnosed with diabetes, another 850 die from its complications, 230 individuals have limbs amputated because of diabetes, 120 people start dialysis, and 55 individuals go blind.

To help put an end to these grim statistics, The University of Texas Health Science Center at Tyler is currently part of a major trial of a drug to prevent diabetes and its life-threatening complications. The drug being tested is called rimonabant. The pharmaceutical firm Sanofi-Aventis makes the drug and is sponsoring the clinical trial.

“If you prevent diabetes, you prevent its crippling health consequences. At the end of the two-year trial, we won’t know if we delay diabetes in people at high risk for developing diabetes or prevent it altogether,” said Dr. David Shafer, director of UTHSCT’s Center for Diabetes Care and the principal investigator of the study at UTHSCT.

“But even delaying the onset for a year or two is a useful thing. People with pre-diabetes have a 10 percent chance each year of developing diabetes,” he said.

The study seeks to enroll 6,000 people who are at high risk of diabetes and live in one of three states: Texas, Louisiana, or California; the Health Center hopes to recruit at least 30 of those, Dr. Shafer said. The Health Center is the only institution in East Texas participating in this study.

Individuals enrolled in this double-blind study will be followed for two years to determine if the drug helps prevent diabetes, Dr. Shafer said. In a double-blind study, neither the investigators nor those enrolled know whether the participants are getting the drug being studied in order not to bias the results. Half of those enrolled will get a placebo, not rimonabant. Participants will receive free lab work, glucose monitoring, and supplies and free physicals during the course of the study.

Rimonabant has already received preliminary approval by the U.S. Food and Drug Administration for weight loss and should be released sometime next year. The drug is known to cause a modest weight loss – eight to 10 pounds – in most people.

That may be the key to how rimonabant works: it may help delay the onset of diabetes because it causes weight loss, he said. Or the drug may help the pancreas produce more insulin or decrease insulin resistance.

“It doesn’t take much weight loss to prevent diabetes. For those with diabetes who do not yet require medication to control their blood sugar, losing as little as five pounds can put their diabetes ‘in remission.’ We know that weight loss works, but fewer than 5 percent of individuals will lose weight and keep it off over a two-year period,” Dr. Shafer said.

People at high risk for diabetes are those who are overweight, have a family history of diabetes, and are older than 35. They can be screened at the Center for Clinical Research to see if they have high blood sugar levels. To be eligible for this study, a person must be at high risk for diabetes, but basically in good health, Dr. Shafer said.

For more information about this study, call the Center for Clinical Research at (903) 877-7753.

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