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Could prozac or DHEA protect against dangerous low blood sugar in diabetes?

NCT ID NCT03228732

Knowledge-focused Sponsor: University of Maryland, Baltimore Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study is testing whether the antidepressant fluoxetine (Prozac) and/or the hormone DHEA can improve the body's ability to defend against low blood sugar in people with type 1 diabetes. About 60 adults will take the drugs or a placebo for 8 weeks, then undergo two-day hospital visits where their responses to low blood sugar are measured. The goal is to understand how these substances affect stress hormones and metabolism, not to treat diabetes itself.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fluoxetine (Prozac) and/or DHEA (dehydroepiandrosterone)
What this could lead to
If it works, this could point toward a way to help people with type 1 diabetes better recognize and respond to low blood sugar, reducing dangerous episodes.
What could go wrong
This is a very early, small study (60 people) testing body responses, not a treatment. The high DHEA dose may have unknown side effects, and results may not lead to a practical therapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2017

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 64 (32 males, 32 females) T1DM patients aged 18-50 yr. * HbA1c \< 11.0% * No clinically diagnosed diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc) * Body mass index \< 40kg · m-2 Exclusion Criteria: * Pregnancy * Subjects unable to give voluntary informed consent * Subjects on anticoagulant drugs, anemic or with known bleeding diatheses * Subjects taking any of the following medications will be excluded: Non-selective Beta Blockers, Sedative-Hypnotics, Anticonvulsants, Antiparkinsonian drugs, Antipsychotics, Antidepressants, Mood stabilizers, CNS Stimulants, Opioids, Hallucinogens * Subjects with a recent medical illness or past history of severe depression, mania or psychotic disease * Subjects that score greater than 50 on the depression scale * Subjects unwillingness or inability to comply with approved contraception measures * Abnormal results following screening tests and physical examination that are clinically significant * Subjects with a history of severe uncontrolled hypertension (i.e., blood pressure greater than 160/100), heart disease, cerebrovascular incidents * Clinically significant cardiac abnormalities (e.g. heart failure, arrhythmias, ischemic tachycardia, S-T segment deviations, etc.) from history or from cardiac stress testing in subjects ≥ 40 years old. * Pneumonia * Hepatic Failure/Jaundice * Creatinine greater than 1.6 mg/dl * Acute Cerebrovascular/ Neurological deficit * Fever greater than 38 °C Screening Laboratory Tests Exclusion Criteria * Hematocrit lower than 32 * WBC lower than 3 thou/ul or greater than 14 thou/ul * Liver Function Tests: SGOT and SGPT greater than twice upper limit of normal range (i.e. greater than 80 U/L). * TBil greater than 2 mg/dl * Alkaline Phosphatase greater than 150U/L * Positive HIV, Hep B, Hep C * Hepatic transaminase \> 2x normal

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 1 diabetes mellitus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Maryland

    RECRUITING

    Baltimore, Maryland, 21201, United States

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