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The Effects of Fluoxetine and/or DHEA
Sponsor: 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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2017-12-19
Completion Date
2026-12-15
Last Updated
2025-10-06
Healthy Volunteers
No
Conditions
Interventions
Placebo Oral Tablet
There will be two 2-day inpatient visits with 8-weeks of treatment with placebo between those visits.
Placebo Oral Tablet
There will be two 2-day inpatient visits with 8-weeks of treatment with placebo between those visits.
Fluoxetine
There will be two 2-day inpatient visits with 8-weeks of treatment with fluoxetine between those visits.
DHEA
There will be two 2-day inpatient visits with 8-weeks of treatment with DHEA between those visits.
Fluoxetine and DHEA
There will be two 2-day inpatient visits with 8-weeks of treatment with fluoxetine and DHEA between those visits.
Locations (1)
University of Maryland
Baltimore, Maryland, United States