Clinical Trials

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.

Official Title:

Genetic Determinants of Response to Metformin in Patients with Type 2 Diabetes

Purpose:

The purpose of this study is to determine which genetic factors influence how African-Americans with type 2 diabetes respond to the diabetes medication Metformin.

Investigator(s):

Kristi Silver, M.D.

Requirements:

African-American between ages 35-89 diagnosed with Type 2 diabetes and have taken Metformin in the past 10 years to treat diabetes

Participation:

1 time visit
Complete questionnaire and blood draw
Receive compensation for your time and effort

 

Contact:

Devon Nwaba 410-706-1724

Official Title:

A Case-Finding Approach to Screening for Monogenic Diabetes

Purpose:

The purpose of our study is to develop a systematic screening and testing approach to detect patients with monogenic diabetes.  Monogenic diabetes results from a change in a single gene, in contrast to the more common type 1 and 2 diabetes, which result from a complex combination of genetic and non-genetic factors.  However, often patients with monogenic diabetes can be initially diagnosed with type 1 or 2 diabetes due to overlapping features.  A properly made diagnosis of monogenic diabetes can lead to improved treatment and outcome for the patient as well as improved ability to assess diabetes risk in family members.       

 

Investigator(s):

Stephanie Stein M.D. and Toni Pollin Ph.D.

Requirements:

Patients of all ages with diabetes who have features indicating an increased chance of having monogenic diabetes; in other words, those who fit one of the following categories:

  1. Diabetes diagnosed before one year of age
  2. Type 1 diabetes and a parent with type 1 diabetes
  3. Type 2 diabetes diagnosed before 30 years of age and not obese at diagnosis
  4. Type 2 diabetes diagnosed before 45 years of age, not obese at diagnosis, and 2 or more relatives diagnosed with diabetes before 50 years of age
  5. Diabetes along with other features that might be part of a syndrome, such as birth defects or hearing loss
  6. Diabetes suspected by a physician to be monogenic or noted to be atypical in some way.

Participation:

1 or 2 study visits

Complete medical and family history and a small blood draw

Receive compensation for your time and effort


Contact:

Tom Fitzgerald or Kathy Palmer (410-706-6140) or email ppgm@medicine.umaryland.edu

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

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, MBBS and Maia Mikeladze, 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:

Maia Mikeladze, M.D., 410-706-5643 

Official Title:

Mechanisms of Hypoglycemia Associated Autonomic Dysfunction: The Effect of SSRI On Exercise

Purpose:

To determine the effects the SSRI (fluoxetine) on exercise associated autonomic dysfunction and endothelial function.

Investigator(s):

Stephen N. Davis MBBS and Maka Hedrington, 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:

Maka Hedrington, M.D., 410-706-5643

Official Title:

Mechanisms of Hypoglycemia Associated Autonomic Dysfunction: GLP-1 and Hypoglycemia

Purpose:

To determine the effects the GLP-1 on hypoglycemia associated autonomic dysfunction and endothelial function.

Investigator(s):

Stephen N. Davis MBBS and Maka Hedrington, 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:

Two 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., 410-706-5643

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, MBBS 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

Official Title:

A Randomized, Double-Blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Pasireotide LAR in Patients with Cushing’s Disease

Purpose:

The purpose of the study is to assess the effectiveness and safety of long-acting release pasireotide in patients with Cushing’s disease.  

Investigator(s):

Kashif Munir, M.D.

Requirements:

Adults with Cushing’s disease who are not candidates for pituitary surgery and who have not received radiation treatment  to the pituitary within the past 10 years.

Participation:

Approximately 16 visits over one year for monthly medication administration and follow up.  There is an option for a 1 year study extension for patients who respond to treatment.  All medications, lab tests, and exams are provided by the study sponsor. Participants may experience improvement of their Cushing's disease, however, this effect cannot be guaranteed. Participants will agree to regular medical tests and examinations.

Contact:

Kashif Munir, MD (kmunir@medicine.umaryland.edu) or Kathy Palmer (kpalmer@medicine.umaryland.edu), 410-706-6140

For more information or to schedule an appointment call 443-682-6800.

This page was last updated: March 26, 2014

         
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