Diabetes 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.
Mechanisms of Hypoglycemia Associated Autonomic Dysfunction: Dose Response of Epinephrine
Purpose: To determine the effects of different dose responses of epinephrine on associated autonomic dysfunction and endothelial function.
Investigator(s): Stephen N. Davis MBBS and Maia Mikeladze, MD
Requirements: Adult, non-smokers with no diabetes, generally healthy without significant cardiovascular disease, age 18-60, BMI >20
Participation: Four separate 1 day overnight (inpatient) stays separated by 2 months each. Sequence of visits is randomized. All labs and medications are provided by the study sponsor. Financial compensation is also provided for time and inconvenience.
Contact: Maia Mikeladze, MD, 410-706-5626
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 Vanessa Briscoe PhD, NP
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: Vanessa Briscoe Ph.D., N.P., 410-706-5643
Mechanisms of Hypoglycemia Associated Autonomic Dysfunction: Differing Levels of Hypoglycemia
Purpose: To determine the effects of different levels of hypoglycemia on associated autonomic dysfunction and endothelial function.
Investigator(s): Stephen N. Davis MBBS and Maka Hedrington, MD
Requirements: Adult, non-smokers with no diabetes, generally healthy without significant cardiovascular disease, age 18-60, BMI >20
Participation: Four separate 1 day overnight (inpatient) stays separated by 2 months each. Sequence of visits is randomized. All labs and medications are provided by the study sponsor. Financial compensation is also provided for time and inconvenience.
Contact: Maka Hedrington, MD, 410-706-5623
Mechanisms of Hypoglycemia Associated Autonomic Dysfunction: Dose Response of Epinephrine
Purpose: To determine the effects of different dose responses of epinephrine on associated autonomic dysfunction and endothelial function.
Investigator(s): Stephen N. Davis MBBS and Maia Mikeladze, MD
Requirements: Adult, non-smokers with no diabetes, generally healthy without significant cardiovascular disease, age 18-60, BMI >20
Participation: Four separate 1 day overnight (inpatient) stays separated by 2 months each. Sequence of visits is randomized. All labs and medications are provided by the study sponsor. Financial compensation is also provided for time and inconvenience.
Contact: Maia Mikeladze, MD, 410-706-5626
Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, SSRI and Exercise
Purpose: To determine if the selective serotonin reuptake inhibitor (SSRI) fluoxetine can improve SNS responses during exercise, and help determine if these types of medications can affect diabetes management.
Investigator(s): Stephen N. Davis MBBS and Maka Hedrington, MD
Requirements: Adult, non-smokers with no diabetes or Type 1 diabetes, generally healthy without significant cardiovascular disease, age 18-45, BMI < 40kg • m-2
Participation: Two separate 1 day overnight (inpatient) stays separated by 8 weeks of treatment with fluoxetine or placebo. All labs and medications are provided by the study sponsor. Financial compensation is also provided for time and inconvenience.
Contact: Maka Hedrington, MD, 410-706-5623
Hypoglycemia Associated Autonomic Failure in Type 1 DM
Purpose: To determine if an over-the-counter dietary supplement containing dehydroepiandrosterone can prevent hypoglycemia associated autonomic failure.
Investigator(s): Stephen N. Davis MBBS and Maia Mikeladze, MD
Requirements: Adult, non-smokers with no diabetes or Type 1 diabetes, generally healthy without significant cardiovascular disease, age 18-45, BMI < 40kg/m-2
Participation: Two separate 2 day overnight (inpatient) stays separated by 6 weeks of treatment with DHEA or placebo. All labs and medications are provided by the study sponsor. Financial compensation is also provided for time and inconvenience.
Contact: Maia Mikeladze, MD, 410-706-5626
Mechanisms of Hypoglycemia Associated Autonomic Dysfunction
Purpose: To determine 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, MD
Requirements: Adult, non-smokers with no diabetes or Type 1 diabetes, generally healthy without significant cardiovascular disease, age 18-50, BMI < 40kg/m-2
Participation: Two separate 2 day overnight (inpatient) stays separated by 6 weeks of treatment with atomoxetine or placebo. All labs and medications are provided by the study sponsor. Financial compensation is also provided for time and inconvenience.
Contact: Maia Mikeladze, MD, 410-706-5626
The effects of the selective serotonin reuptake inhibitor, fluoxetine and/or DHEA, on neuroendocrine, autonomic nervous system and metabolic counterregulatory responses during repeated hypoglycemia in T1DM individuals
Purpose:
- To determine how the Selective Serotonin Reuptake Inhibitor (SSRI), fluoxetine (Prozac), an antidepressant often used to treat depression, stimulates your body's ability to defend itself from low blood sugar (hypoglycemia).
- To learn how a hormone, dehydroepiandrosterone (DHEA), stimulates your body's ability to defend itself from low blood sugar (hypoglycemia). DHEA is a hormone produced naturally in the human body. It can be made in a laboratory and is sold as an over-the-counter dietary supplement. The dose we are giving in this study is higher than the usual recommended dosage taken as a supplement for certain medical conditions.
- To study combined effects of fluoxetine and DHEA during low blood glucose. In the present study, we will measure your body's responses to hypoglycemia when given fluoxetine or DHEA or fluoxetine and DHEA or a placebo (a pill with no fluoxetine or DHEA)
Investigator(s): Stephen N. Davis MBBS and Maka Hedrington, MD
Requirements: Adult, non-smokers with Type 1 diabetes, generally healthy without significant cardiovascular disease, age 18-50, BMI < 40kg • m-2
Participation: Two separate 2 day overnight (inpatient) stays separated by 8 weeks of treatment with placebo, fluoxetine, DHEA or fluoxetine and DHEA. All labs and medications are provided by the study sponsor. Financial compensation is also provided for time and inconvenience.
Contact: Maka Hedrington, MD, 410-706-5623
Clinical study of salivary glycated albumin
Purpose: To determine whether the SmartAlbu (a portable hand held device that non-invasively detects the ratio of salivary GA over total albumin) represents a precise non-invasive clinical measurement of short term glycemic control (2-3 weeks) by comparing the ratio of GA and HSA in saliva with (1) the same ratio in blood and (2) HbA1c.
Investigator(s): Stephen N. Davis MBBS and Maka Hedrington, MD
Requirements: Adult, non-smokers with no diabetes, Type 1 or Type 2 diabetes, generally healthy without significant cardiovascular disease, age 18-80, BMI >18.5 kg/m2
Participation: The nurses will draw small amount of blood (approximately 1 teaspoon) and ask to deposit saliva into a small container. Financial compensation is provided for time and inconvenience.
Contact: Maka Hedrington, MD, 410-706-5623