Clinical trials are studies designed to find new and better ways to treat patients with diabetes. The physicians in the University of Maryland Diabetes Network are currently conducting the clinical trials listed below.
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.
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| Investigator(s):
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Stephanie Stein M.D., Toni Pollin Ph.D., Alan Shuldiner M.D., Ravi Kant M.D., Kristi Silver M.D., Elizabeth Streeten M.D., Kristin Maloney, M.S., MGC
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| Requirements:
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We are interested in recruiting patients of all ages with diabetes with features indicating an increased chance of having monogenic diabetes; i.e., those who fit one of the following categories:
- Diabetes diagnosed before 6 months of age
- Type 1 diabetes and a parent with type 1 diabetes
- Type 2 diabetes diagnosed before 30 years of age and not obese at diagnosis
- 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
- Diabetes along with other features that might be part of a syndrome, such as birth defects or hearing loss
- Diabetes suspected by a physician to be monogenic or noted to be atypical in some way.
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| Participation:
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An initial visit with our study coordinator and/or genetic counselor for 1 hour. A blood draw would occur at this visit. There would then be a follow-up visit with our study coordinator and/or genetic counselor which would also last about 1 hour.
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| Contact:
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Kathleen Palmer, Tom Fitzgerald, 410-706-6140
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Epidemiology of Diabetes Interventions and Complications
| Purpose:
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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.
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| Investigator(s):
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| Requirements:
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Participant in DCCT
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| Contact:
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Sherry, 410-328-3411
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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.
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| Investigator(s):
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Kristi Silver, M.D.
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| Requirements:
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African-American between ages 35-89 diagnosed with Type 2 diabetes and have taken Metformin in the past 10 years to treat diabetes
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| Participation:
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1 time visit
Complete questionnaire and blood draw
Receive compensation for your time and effort
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| Contact:
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Devon Nwaba, 410-706-1724
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TrialNet
| Purpose:
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To screen siblings, parents, and children of people with Type 1 diabetes for diabetes risk, and to develop methods to prevent Type 1 diabetes.
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| Investigator(s):
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| Requirements:
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Age 4-45
Relative of someone with Type 1 diabetes
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| Contact
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Mary, 410-328-5419
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A Phase 3b Study to Evaluate the Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients with Stable Cardiovascular Disease and Glucose Abnormalities
| Purpose:
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The Aleprevent study is looking at the effect of an investigational medication on the risk of having a cardiovascular emergency such as a heart attack or stroke in the future.
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| Investigator(s):
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Michael Miller, M.D.
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| Requirements:
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You must be at least 40 years of age, have cardiovascular disease (e.g., a previous heart attack or stroke or peripheral arterial disease), and have type 2 diabetes or raised blood sugar levels.
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| Participation:
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Approximately 10 outpatient visits over 3 years. Financial compensation is provided.
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| Contact:
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Rachel Grice, 410-328-2451
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Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 3
| Clinical Trial Detail:
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DHEA |
| Purpose:
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To determine the effects of the nutritional supplement, DHEA, on hypoglycemia associated autonomic dysfunction.
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| Investigator(s):
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Stephen N. Davis, MBBS and Maia Mikeladze, M.D.
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| Requirements:
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Adults with no diabetes or type 1 diabetes generally healthy with no micro/macro-vascular complications, age 18-45, BMI <40, A1C<11%
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| Participation:
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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.
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| Contact:
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Maia Mikeladze, M.D., 410-706-5626
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Mechanisms of Hypoglycemia Associated Autonomic Dysfunction: The Effect of Alprazolam On Exercise Induced Hypoglycemia
| Clinical Trial Detail:
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Alprazolam/Exercise
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| Purpose:
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To determine the effects of alprazolam (Xanax) via GABA activation on hypoglycemia associated autonomic dysfunction.
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| Investigator(s):
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Stephen N. Davis, MBBS and Maka Hedrington M.D.
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| Requirements:
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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
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| Participation:
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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.
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| Contact:
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Maka Hedrington M.D., 410-706-5623
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Mechanisms of Ramipril Reduction in the Onset of Type 2 Diabetes
| Clinical Trial Detail:
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Ramipril |
| Purpose:
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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.
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| Investigator(s):
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Stephen N. Davis, MBBS and Cheryl Young, CRNP
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| Requirements:
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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.
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| Participation:
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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.
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| Contact:
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Cheryl Young, CRNP 410-706-5641
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Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q.4-Atomoxetine
| Clinical Trial Detail:
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Atomoxetine |
| Purpose:
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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.
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| Investigator(s):
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Stephen N. Davis, MBBS and Nino Joy, M.D.
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| Requirements:
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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.
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| Participation:
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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.
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| Contact:
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Nino Joy, M.D., 410-706-5636
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Mechanisms of Hypoglycemia Associated Autonomic Dysfunction: The Effect of SSRI On Exercise
| Clinical Trial Detail:
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SSRI and Exercise
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| Purpose:
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To determine the effects the SSRI (fluoxetine) on exercise associated autonomic dysfunction and endothelial function.
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| Investigator(s):
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Stephen N. Davis MBBS and Maka Hedrington, M.D.
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| Requirements:
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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
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| Participation:
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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.
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| Contact:
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Maka Hedrington, M.D., 410-706-5623
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