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
University of Maryland, Baltimore
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.
Eligibility
- Age range
- 18–50 years
- Sex
- All
- Healthy volunteers
- No
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, M…
Interventions
- DrugPlacebo Oral Tablet
There will be two 2-day inpatient visits with 8-weeks of treatment with placebo between those visits.
- DrugPlacebo Oral Tablet
There will be two 2-day inpatient visits with 8-weeks of treatment with placebo between those visits.
- DrugFluoxetine
There will be two 2-day inpatient visits with 8-weeks of treatment with fluoxetine between those visits.
- DrugDHEA
There will be two 2-day inpatient visits with 8-weeks of treatment with DHEA between those visits.
- DrugFluoxetine and DHEA
There will be two 2-day inpatient visits with 8-weeks of treatment with fluoxetine and DHEA between those visits.
Location
- University of MarylandBaltimore, Maryland