drugset / Trial / NCT03228732

The Effects of Fluoxetine and/or DHEA

NCT03228732

Phase 0 Recruiting 60 enrolled University of Maryland, Baltimore
RandomizedParallel-groupDouble-blindOther

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.

Timeline

Start
2017-12-19
Primary completion
2026-09-15
Completion
2026-12-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dehydroepiandrosterone Other / unclassified
Comparator Fluoxetine Small molecule