The Effects of Fluoxetine and/or DHEA

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT03228732
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

(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.

Key Dates

Start date
Dec 19, 2017
Status verified
Sep 2025
Primary completion
Sep 15, 2026
Completion
Dec 15, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Placebo Comparator: Placebo 1
    Visit 1: Study Day 1: Hyperinsulinemia/ euglycemia clamp in the AM and PM. Study Day 2: Hyperinsulinemia/ hypoglycemia clamp in the AM only. 8-weeks of treatment with placebo Visit 2: same as visit 1
  • Placebo Comparator: Placebo 2
    Visit 1: Study Day 1: Hyperinsulinemia/ hypoglycemia clamp in the AM and PM. Study Day 2: Hyperinsulinemia/ hypoglycemia clamp in the AM only. 8-weeks of treatment with placebo Visit 2: same as visit 1
  • Active Comparator: Fluoxetine
    Visit 1: Study Day 1: Hyperinsulinemia/ hypoglycemia clamp in the AM and PM. Study Day 2: Hyperinsulinemia/ hypoglycemia clamp in the AM only. 8-weeks of treatment with fluoxetine Visit 2: same as visit 1
  • Active Comparator: DHEA
    Visit 1: Study Day 1: Hyperinsulinemia/ hypoglycemia clamp in the AM and PM. Study Day 2: Hyperinsulinemia/ hypoglycemia clamp in the AM only. 8-weeks of treatment with DHEA Visit 2: same as visit 1
  • Active Comparator: Fluoxetine and DHEA
    Visit 1: Study Day 1: Hyperinsulinemia/ hypoglycemia clamp in the AM and PM. Study Day 2: Hyperinsulinemia/ hypoglycemia clamp in the AM only. 8-weeks of treatment with fluoxetine and DHEA Visit 2: same as visit 1

Primary Outcome Measure

Change in the level of catecholamines in plasma [ Time Frame: An average of 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MarylandBaltimoreMaryland21201
Maka Siamashvili, MD
[email protected]
410-706-5623

Find similar trials in Baltimore, MD

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
University of Maryland· Baltimore, MD

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