The Effects of Fluoxetine and/or DHEA

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

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.

Sponsors & Collaborators

• University of Maryland, Baltimore

  lead OTHER

Principal Investigators

• Stephen N Davis, MBBS · University of Maryland, Baltimore

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-12-19

Primary Completion

2026-09-15

Completion

2026-12-15

FDA Drug

Yes

Countries

• United States

Study Locations