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
Overview
- Phase
- Early Phase 1
- Intervention
- Placebo Oral Tablet
- Conditions
- Type 1 Diabetes Mellitus
- Sponsor
- University of Maryland, Baltimore
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in the level of catecholamines in plasma
- Status
- Recruiting
- Last Updated
- 6 months ago
Overview
Brief Summary
(1) To determine how the Selective Serotonin Reuptake Inhibitor (SSRI), fluoxetine (Prozac), an antidepressant often used to treat depression, stimulates the participant's body's ability to defend against low blood sugar (hypoglycemia). (2) To learn how a hormone, dehydroepiandrosterone (DHEA), stimulates the participant's body's ability to defend itself from low blood sugar (hypoglycemia). DHEA is a hormone produced naturally in the human body. However, it can be manufactured and is sold as an over-the-counter dietary supplement. The dose the investigators are giving in this study is higher than the usual recommended dosage taken as a supplement for certain medical conditions. (3) To study combined effects of fluoxetine and DHEA during low blood glucose. In the present study, the investigators will measure the participant's body's responses to hypoglycemia when given fluoxetine or DHEA or fluoxetine and DHEA or a placebo (a pill with no fluoxetine or DHEA). Approximately 64 individuals with type 1 diabetes will take part in this study.
Investigators
Stephen N. Davis, MBBS
Chairman of Medicine
University of Maryland, Baltimore
Eligibility Criteria
Inclusion Criteria
- •64 (32 males, 32 females) T1DM patients aged 18-50 yr.
- •HbA1c \< 11.0%
- •No clinically diagnosed diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc)
- •Body mass index \< 40kg · m-2
Exclusion Criteria
- •Pregnancy
- •Subjects unable to give voluntary informed consent
- •Subjects on anticoagulant drugs, anemic or with known bleeding diatheses
- •Subjects taking any of the following medications will be excluded: Non-selective Beta Blockers, Sedative-Hypnotics, Anticonvulsants, Antiparkinsonian drugs, Antipsychotics, Antidepressants, Mood stabilizers, CNS Stimulants, Opioids, Hallucinogens
- •Subjects with a recent medical illness or past history of severe depression, mania or psychotic disease
- •Subjects that score greater than 50 on the depression scale
- •Subjects unwillingness or inability to comply with approved contraception measures
- •Abnormal results following screening tests and physical examination that are clinically significant
- •Subjects with a history of severe uncontrolled hypertension (i.e., blood pressure greater than 160/100), heart disease, cerebrovascular incidents
- •Clinically significant cardiac abnormalities (e.g. heart failure, arrhythmias, ischemic tachycardia, S-T segment deviations, etc.) from history or from cardiac stress testing in subjects ≥ 40 years old.
Arms & Interventions
Placebo 1
Visit 1: Study Day 1: Hyperinsulinemia/ euglycemia clamp in the AM and PM. Study Day 2: Hyperinsulinemia/ hypoglycemia clamp in the AM only. 8-weeks of treatment with placebo Visit 2: same as visit 1
Intervention: Placebo Oral Tablet
Placebo 2
Visit 1: Study Day 1: Hyperinsulinemia/ hypoglycemia clamp in the AM and PM. Study Day 2: Hyperinsulinemia/ hypoglycemia clamp in the AM only. 8-weeks of treatment with placebo Visit 2: same as visit 1
Intervention: Placebo Oral Tablet
Fluoxetine
Visit 1: Study Day 1: Hyperinsulinemia/ hypoglycemia clamp in the AM and PM. Study Day 2: Hyperinsulinemia/ hypoglycemia clamp in the AM only. 8-weeks of treatment with fluoxetine Visit 2: same as visit 1
Intervention: Fluoxetine
DHEA
Visit 1: Study Day 1: Hyperinsulinemia/ hypoglycemia clamp in the AM and PM. Study Day 2: Hyperinsulinemia/ hypoglycemia clamp in the AM only. 8-weeks of treatment with DHEA Visit 2: same as visit 1
Intervention: DHEA
Fluoxetine and DHEA
Visit 1: Study Day 1: Hyperinsulinemia/ hypoglycemia clamp in the AM and PM. Study Day 2: Hyperinsulinemia/ hypoglycemia clamp in the AM only. 8-weeks of treatment with fluoxetine and DHEA Visit 2: same as visit 1
Intervention: Fluoxetine and DHEA
Outcomes
Primary Outcomes
Change in the level of catecholamines in plasma
Time Frame: An average of 3 years