Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Early Phase 1

The Effects of Fluoxetine and/or DHEA

NCT03228732 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 60 participants
Start Date 2017-12-19
Est. Completion 2026-12-15
Phase Early Phase 1

Sponsor

University of Maryland, Baltimore

559 total trials

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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. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Maryland, Baltimore, which has 559 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03228732 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03228732?

This trial is sponsored by University of Maryland, Baltimore, which has 559 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial