Stony Brook seeks volunteers with pre-diabetes for three-month clinical trial

For obese individuals who are insulin-resistant and therefore prone to developing type 2 diabetes, taking low dose doxycycline may reduce the risk of developing diabetes. The Stony Brook Medicine “Doxycycline for treatment of insulin resistance in obesity” study is seeking participants for the three-month clinical trial. Compensation for volunteers is up to $450.

More than one-third of American adults are considered obese. When fat tissue growth fails to keep up with caloric intake, excess fat accumulates in muscle and liver making metabolites decrease insulin’s impact on tissues. In this process, some individuals develop pre-diabetes. While reducing dietary intake and increasing physical activity can reduce insulin resistance, some obese individuals may find these lifestyle changes difficult. Doxycycline may provide an additional help.

According to Marie Gelato, MD, PhD, Principal Investigator and Distinguished Service Professor in the Department of Medicine, the innovation of doxycycline treatment for obese individuals with insulin resistance is based on the mechanism of action of the drug. Doxycycline reduces inflammation related to being overweight, exhibits cellular improvement of insulin resistance, and improves vascular changes associated with hypertension.

“The purpose of this clinical trial with doxycycline is to see if the drug with its multiple mechanisms of action reduces inflammation and insulin resistance in this population,” said Dr. Gelato. “If doxycycline does that effectively and consistently, it may reduce not only the risk of developing diabetes but also high blood pressure or heart disease.”

The clinical trial consists of being randomly assigned to take either a low dose of doxycycline twice a day (a common formulation used to treat gum disease), or a placebo (inactive substance) for three months. Volunteers from both groups will also undergo tests for improvement in insulin resistance and reduction in inflammation.

Stony Brook University supports medical advances for our patients through safe and ethical research involving volunteers from our surrounding community. Stony Brook University is accredited through the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP), and has an approved assurance of compliance with the Federal Office for Human Research Protections. For more information on what it means to be a research subject, as well as how to participate in approved research studies conducted at Stony Brook University, please visit the Community/Research Participant Corner on the Stony Brook University website.

Eligibility criteria for the clinical trial includes being age 18 or over, having a body mass index of greater than 30, and being insulin resistant but otherwise healthy without other existing conditions. For more information, please call Stony Brook’s Clinical Research Center at 631-444-1175.