UAB Synopsis, Vol. 27, No. 29, July 28, 2008

The reorganized Diabetes and Endocrine Clinical Research Unit (DECRU) is expected to play a major role when the Multidisciplinary Comprehensive Diabetes Center (MCDC) opens later this summer.

Fernando Ovalle, MD, is director of both the MCDC and the DECRU. Both units are part of the Division of Endocrinology, Diabetes, and Metabolism.

“The DECRU will work closely with the MCDC to enter all consenting patients in a new database indicating whether they are interested in participating in clinical trials,” Dr. Ovalle says. “This database will help us and potential participants with specific clinical studies. It also will benefit epidemiological, outcomes, and other patient-oriented studies of the UAB Comprehensive Diabetes Center.”

“Clinical research is important in helping us get early experience and stay abreast of the newest drugs, devices, and treatment algorithms coming to market,” he says. “It also allows us to offer additional options to our patients, some in cases for which there are no good alternatives.”

Most clinical studies now underway by the research unit involve diabetes; its related metabolic disorders, including obesity, dyslipidemia, hypertension, endothelial dysfunction, and polycystic ovary syndrome; and its micro- and macrovascular complications, including diabetic retinopathy, nephropathy, neuropathy, and cardiac and peripheral vascular disease, among others.

The MCDC and the research unit will be one of the first in the world to test a plasmid DNA intramuscular injection containing the genetic code for proinsulin for the treatment of type 1 diabetes. “Our unit soon will be the first center in the US to use adult mesenchymal stem cells for the treatment of type 1 diabetes,” he says. “Furthermore, we are among the most experienced in the nation with anti-CD4 monoclonal antibodies for type 1 diabetes, based on the volume of participants we have recruited in the last 2 years.”

For type 2 diabetes, the research unit is testing various management algorithms for the management of hyperglycemia and stable coronary disease, with the goal of determining the best way to prevent or reduce major cardiovascular events. The NIH-funded, multicenter trial is named the Bypass Angioplasty Revascularization Investigation-2 Diabetes (BARI-2D) study. In August the DECRU will open for enrollment another large NIH-funded, multicenter trial, Targeting Inflammation Using Salsalate for Type 2 Diabetes (TINSAL-2D).

The unit is capable of performing phases 1, 2, 3, and 4 of clinical research, including in- and outpatient studies. The unit also conducts nondiabetes trials involving other endocrine or metabolic disorders, currently including a Cushing syndrome study using a glucocorticoid receptor antagonist for patients not responsive to conventional treatments, a cardiovascular outcomes study using an endocannabinoid receptor antagonist for patients at high risk for cardiovascular disease, and a hyperlipidemia study.

Dr. Ovalle is principal investigator for most of the current clinical trials. Sub-investigators include Carlos Arguello, MD, T. Brooks Vaughan, MD, and Amy H. Warriner, MD.

Three research nurses staff the research unit. They are Tiffany Grimes, RN, Melanie Smith, RN, and Marianne Vetrano, RN.

For more information go to the DECRU Web site at http://endo.dom.uab.edu/clinicalresearch/.