NCT03228732

The Effects of Fluoxetine and/or DHEA

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Placebo Oral Tablet	There will be two 2-day inpatient visits with 8-weeks of treatment with placebo between those visits.
DRUG	Placebo Oral Tablet	There will be two 2-day inpatient visits with 8-weeks of treatment with placebo between those visits.
DRUG	Fluoxetine	There will be two 2-day inpatient visits with 8-weeks of treatment with fluoxetine between those visits.
DRUG	DHEA	There will be two 2-day inpatient visits with 8-weeks of treatment with DHEA between those visits.
DRUG	Fluoxetine and DHEA	There will be two 2-day inpatient visits with 8-weeks of treatment with fluoxetine and DHEA between those visits.

Timeline

• Start date: 2017-12-19
• Primary completion: 2026-09-15
• Completion: 2026-12-15
• First posted: 2017-07-25
• Last updated: 2025-10-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study