University of Maryland Center for Diabetes and Endocrinology

UMMC's Diabetes and Endocrinology Program ranked as one of the nation's 50 best by U.S. News & World Report's 2010 "Best Hospitals" survey.

Clinical Trials We're Currently Enrolling Patients For

Clinical trials are studies designed to find new and better ways to treat patients with diabetes. The physicians at the University of Maryland Center for Diabetes and Endocrinology are currently conducting the clinical trials listed below.

1. Clinical Trial Detail - UCP2
Official Title:	Uncoupling Protein Polymorphisms and Cardiometabolic Responses to Beta-Blockers
Purpose:	This study examines the genetic factors that may influence how atenolol, a beta-blocker medication, affects fat breakdown, blood sugar levels, and heart function in people with type 2 diabetes.
Investigator(s):	Amber Beitelshees, PharmD, MPH
Requirements:	Adult with type 2 diabetes of at least a year's duration, not being treated with insulin or a beta-blocker
Participation:	Approximately 7 outpatient visits over a 10-week period. Study includes an ultrasound of the heart, an IV glucose tolerance test, and a biopsy of fat and muscle before and after 8 weeks of medication. Financial compensation is provided for time and inconvenience.
Contact:	Tara Mease, 410-706-1724
2. Clinical Trial Detail: PPAR
Official Title:	Pharmacogenomics of Thiazolidinediones
Purpose:	To study individual response to an insulin-sensitizing medicine in people who are pre-diabetic or non-diabetic.
Investigator(s):	Soren Snitker, M.D., Ph.D.
Requirements:	Between ages of 35 & 70 years, Caucasian, generally healthy
Participation:	Approximately three months of treatment with diabetes medicine (pioglitazone ACTOS), followed by 10-week weight-loss program. Four to six visits in initial three-month treatment. Weekly visits for weight-loss program. Financial compensation provided for time.
Contact:	Soren Snitker, 410-328-7254

3. Epidemiology of Diabetes Interventions and Complications
Official Title:	Epidemiology of Diabetes Interventions and Complications
Purpose:	To study diabetes complications in people with Type 1 diabetes who participated in the Diabetes Complications and Control Trial to assess long term effects of intensive management.
Investigator(s):	Debra Counts, M.D.
Requirements:	Participant in DCCT
Contact:	Sherry 410-328-3411
4. TrialNet
Official Title:	TrialNet
Purpose:	To screen siblings, parents, and children of people with Type 1 diabetes for diabetes risk, and to develop methods to prevent Type 1 diabetes.
Investigator(s):	Debra Counts, M.D.
Requirements:	Age 4 - 45 Relative of someone with Type 1 diabetes
Contact:	Mary 410-328-5419

5. Clinical Trial Detail: DHEA
Official Title:	Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 3
Purpose:	To determine the effects of the nutritional supplement, DHEA, on hypoglycemia associated autonomic dysfunction.
Investigator(s):	Stephen N. Davis, M.D. and Maia Mikeladze, M.D.
Requirements:	Adults with no diabetes or type 1 diabetes generally healthy with no micro/macro-vascular complications, age 18-45, BMI <40, A1C<11%
Participation:	Study involves two overnight (inpatient) stays with a 6 week drug therapy period in between. Outpatient visits during study drug therapy are biweekly and include B/P check, labs, and dispensing of daily oral study drug. Crossover of the 6 week trial may be performed. All labs and medications are provided by the study sponsor. Financial compensation is also provided for time and inconvenience.
Contact:	Maia Mikeladze, M.D., 410-706-5626
6. Clinical Trial Detail: Alprazolam/Exercise
Official Title:	Mechanisms of Hypoglycemia Associated Autonomic Dysfunction: The Effect of Alprazolam On Exercise Induced Hypoglycemia
Purpose:	To determine the effects of alprazolam (Xanax) via GABA activation on hypoglycemia associated autonomic dysfunction.
Investigator(s):	Stephen N. Davis, M.D. and Maka Hedrington M.D.
Requirements:	Adults with type 1 diabetes (A1C >6%) with no micro/macro-vascular complications, age 18-50, BMI <35, able to perform some exercise on stationary bicycle
Participation:	Four 2 day overnight (inpatient) stays separated by 2 months each. Inpatient visits include insulin infusion at normal and high levels, blood glucose manipulation to normal and low levels, tracer infusion, indirect calorimetry (with and without exercise), and oral study drug administration. All labs and medications are provided by the study sponsor. Financial compensation is also provided for time and inconvenience.
Contact:	Maka Hedrington M.D., 410-706-5623
7. Clinical Trial Detail: Ramipril
Official Title:	Mechanisms of Ramipril Reduction in the Onset of Type 2 Diabetes
Purpose:	The purpose of the study is to determine how Ramipril (Altace), used for treating high blood pressure, can affect glucose levels in people who are at risk for diabetes.
Investigator(s):	Stephen N. Davis, M.D. and Cheryl Young, CRNP
Requirements:	Non-smoking adults with impaired glucose tolerance and moderately uncontrolled hypertension (B/P 120/80-150/100) on no diabetes, ACE-I, HCTZ, or ARB therapy, age 20-65, BMI >25.
Participation:	Six months of study drug therapy with weekly x4 then monthly outpatient visits with 2-day overnight (inpatient) stays prior to and post drug therapy. Outpatient visits include drug titration, daily self-administered study drug dispensing, labs, blood glucose and B/P monitoring. Inpatient visits include insulin infusion at normal and high levels, blood glucose control to normal level, tracer infusion, metabolic measures, brachial artery ultrasound, IV Glucose Tolerance Test, and nerve activity. All labs and medications are provided by the study sponsor. Financial compensation is also provided for time and inconvenience.
Contact:	Cheryl Young, CRNP 410-706-5641

8.Clinical Trial Detail: Atomoxetine
Official Title:	Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q.4-Atomoxetine
Purpose:	The purpose of this study is to see if the drug atomoxetine (Strattera) has effects on the body’s ability to defend itself against low blood sugar.
Investigator(s):	Stephen N. Davis, M.D. and Maka Hedrington M.D.
Requirements:	Adults with no diabetes or type 1 diabetes with no significant cardiovascular disease or narrow angle glaucoma, age 18-50, BMI <40, not on MAOI’s.
Participation:	Study involves two overnight (inpatient) stays with a 6 week drug therapy period in between. Weekly visits during study drug therapy include B/P check, labs, dose titration, blood glucose monitoring, and dispensing of the oral study drug. Crossover of the 6 week trial may be performed. All labs and medications are provided by the study sponsor. Financial compensation is also provided for time and inconvenience.
Contact:	Maka Hedrington M.D., 410-706-5623
9. Clinical Trial Detail: SCCOR 3
Official Title:	Metabolic Causes of Thrombosis In Type 2 Diabetes Question 3
Purpose:	The purpose of this study is to learn more about why patients with diabetes have increased heart attacks, strokes and other illnesses due to blood clots causing blockage of a blood vessel.
Investigator(s):	Stephen N. Davis M.D. and Nino Joy M.D.
Requirements:	Adult, non-smokers with no diabetes or type 2 diabetes (A1C >5.5% , and diabetes duration <20yrs), generally healthy without significant cardiovascular disease, without history of pancreatitis, age 18-60, BMI >20
Participation:	Four 1 day overnight (inpatient) stays separated by 2 months each. Sequence of visits are randomized. All labs and medications are provided by the study sponsor. Financial compensation is also provided for time and inconvenience.
Contact:	Nino Joy M.D., 410-706-5636
10. Clinical Detail: SCCOR 4
Official Title:	Metabolic Causes of Thrombosis In Type 2 Diabetes Question 4
Purpose:	The purpose of this study is to learn more about why patients with diabetes have increased heart attacks, strokes and other illnesses due to blood clots causing blockage of a blood vessel.
Investigator(s):	Stephen N. Davis M.D. and Nino Joy M.D.
11. Immune Tolerance Network: RETAIN Study
Official Title:	Immune Tolerance Network: RETAIN Study (Effect of Intravenous alpha-1-Antitrypsin on Preserving ß -cell Function in New-onset Type 1 Diabetes Mellitus - ITN041A)
Purpose:	To test alpha-1-Antitrypsin in people between 8 - 35 years with newly diagnosed with Type 1 diabetes for safety and to see how the drug lasts as a step in finding if this drug will help the remaining insulin-producing ability be preserved.
Investigator(s):	Debra Counts, M.D.
Requirements:	Age 8 - 35 years, Type 1 Diabetes diagnosed < 3 months ago
Contact:	Mary at 410-328-5419 or Dr. Counts at 410-328-3412
12. Immune Tolerance Network: T1DAL Study
Official Title:	Immune Tolerance Network: T1DAL Study (Inducing Remission in New Onset T1DM with Alefacept (Amevive®) ITN045AI)
Purpose:	To test Alefacept in people between 12 - 35 years with newly diagnosed with Type 1 diabetes for safety and to see how the drug lasts as a step in finding if this drug will help the remaining insulin-producing ability be preserved.
Investigator(s):	Parissa Salemi, D.O., and Debra Counts, M.D.

This page was last updated on: October 19, 2011.

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