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NCT03228732 · ClinicalTrials.gov registry record · Early Phase 1
The Effects of Fluoxetine and/or DHEA
A Early Phase 1 study of Type 1 Diabetes Mellitus, sponsored by University of Maryland, Baltimore.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT03228732 is a Early Phase 1 study of Type 1 Diabetes Mellitus that is actively recruiting participants, run by University of Maryland, Baltimore. The registered enrollment target is 60 participants, below the 140-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03228732, a Early Phase 1 study of Type 1 Diabetes Mellitus, is actively recruiting participants, sponsored by University of Maryland, Baltimore.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG Placebo Oral Tablet
- DRUG Fluoxetine
- DRUG DHEA
- DRUG Fluoxetine and DHEA
Study Locations (1)
Maryland
- University of Maryland - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2017-12-19 |
| Est. Completion | 2026-12-15 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03228732
The ClinicalTrials.gov registry entry for NCT03228732 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 140-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (57% lower). The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 4 interventions - of which Placebo Oral Tablet is the first listed.
NCT03228732 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT03228732 about?
NCT03228732 is a clinical study titled "The Effects of Fluoxetine and/or DHEA". (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), stim...
What is the current status of trial NCT03228732?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 60 participants. The study started on 2017-12-19. Estimated completion is 2026-12-15.
What conditions does trial NCT03228732 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT03228732?
The interventions under investigation include: Placebo Oral Tablet (DRUG), Fluoxetine (DRUG), DHEA (DRUG), Fluoxetine and DHEA (DRUG).
Who is sponsoring clinical trial NCT03228732?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03228732 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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