Thomas Jefferson University Hospital
 
DIVISION OF ENDOCRINOLOGY, DIABETES AND METABOLIC DISEASES

Diabetes Research Center

Director: Barry J. Goldstein, MD, PhD
Phone: 215-955-1978
Fax: 215-955-8863

The Diabetes Research Center functions under the auspices of the Division of Endocrinology, Diabetes and Metabolic Diseases at Thomas Jefferson University. The Center has been performing a wide variety of diabetes-related clinical research studies since 1992. Our experienced research staff consists of full-time Faculty (Board-Certified Endocrinologists), Clinical Endocrinology Fellows (Board Certified in Internal Medicine), Nurses, Medical Assistants, Nutritionists, Certified Diabetes Educators, and other administrative professionals.

The Diabetes Research Center has experience in both Federally-funded and Pharmaceutical industry –supported clinical trials. For the Diabetes Prevention Program (DPP), we have been serving as one of 27 centers in the USA to follow a cohort of ~150 patients with impaired glucose tolerance to determine whether lifestyle modification or medications can prevent or delay the onset of Type 2 Diabetes or its vascular complications. This study is currently in an extension phase, known as DPPOS (DPP Outcomes Study) until 2008.

For Industry-supported studies, we have evaluated new insulin analogs, new drugs and delivery systems for the management of high glucose levels (including inhaled and long-acting insulins), and novel medications for prevention or management of the complications of diabetes, including hypertension, lipid disorders, gastroparesis and erectile dysfunction, in patients with both Type 1 and Type 2.

Serving as principal investigators of the clinical trials at the Diabetes Research Center are Drs. Barry J. Goldstein, Jeffrey L. Miller, Serge Jabbour and Intekhab Ahmed.  Leslie Massara, CCRC is our senior clinical research coordinator; Louba Block, MS-PA-c is a study coordinator and subinvestigator.

Current Clinical Trials at the Diabetes Research Center
We are currently seeking participants for the following clinical trials:

(Clinical Trials as of January 2005)

  1. Lantus® Insulin vs. Standard Care and Omega-3 fatty acids (fish oil) vs. placebo on reducing the number of deaths related to heart problems. To participate in this trial, subjects:
    • must have Type 2 Diabetes
    • must have impaired fasting glucose or
    • must have impaired glucose tolerance
    • must currently be managing their blood glucose with diet and exercise OR be taking only one oral diabetes medication.

  2. A research study designed to determine the safety and effects of an investigational new drug, Tesaglitazar (0.5mg) when used in combination with insulin in type 2 diabetics. To participate in this trial, subjects:
    • must have Type 2 Diabetes
    • must currently be receiving at least 30 units of insulin per day
    • can be using 1 or 2 oral medications to treat Diabetes in addition to insulin

  3. A research study to look at the efficacy and safety of CS-917 200mg bid, 400mg  in patients with Type 2 Diabetes. There will be a total of 7 visits. To participate in the study eligible participants:
    • must have Type 2 Diabetes
    • must be treating Diabetes with diet and exercise OR on one oral agent to treat Diabetes.

  4. Open-Label Study of Renal Effects of Tesaglitazar in Patients with Type 2 Diabetes Mellitus. To participate in this trial, subjects:
    • must have Type 2 Diabetes
    • must be at least 45 years of age
    • must be treating Diabetes with diet and exercise OR on one or more oral agents to treat Diabetes

For more information regarding participation in these studies or any general questions you may have regarding diabetes clinical trials at the Diabetes Research Center at Jefferson, please contact Leslie Massara, CCRC at 215-955-1978 or e-mail leslie.padron-massara@jefferson.edu.