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RECRUITING
NCT03228732
EARLY_PHASE1

The Effects of Fluoxetine and/or DHEA

Sponsor: University of Maryland, Baltimore

View on ClinicalTrials.gov

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

Interventions

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.

Locations (1)

University of Maryland

Baltimore, Maryland, United States