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Prozac may reduce Exercise-Related low blood sugar in type 1 diabetes

NCT ID NCT01672255

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This early study tests whether the antidepressant fluoxetine (Prozac) can improve the body's nervous system response during exercise in people with type 1 diabetes. Many with diabetes avoid exercise due to fear of low blood sugar. The study includes 64 adults—half with type 1 diabetes and half healthy—who take either Prozac or a placebo for 6 weeks. Researchers measure stress hormone levels during exercise to see if Prozac helps the body respond better.

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)
What this could lead to
If successful, this could point toward a way to help people with type 1 diabetes exercise more safely by reducing their risk of low blood sugar.
What could go wrong
This is a very early, small study with only 64 participants. It tests a theory, not a proven treatment, and results may not lead to any practical change.

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 64 people

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

Start date

Oct 2012

Finished

May 2025

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 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * 32 (16 males, 16 females) Healthy controls aged 18-45 yr. * 32 (16 males, 16 females) Type 1 diabetic patients aged 18-45 yr. * HbA1c 6-10.0% * Has been diagnosed Type 1 DM * No clinically diagnosed diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc) * Body mass index \< 40kg • m-2 Exclusion Criteria: * Pregnant women * 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 * Subjects with a history of hypertension, heart disease, cerebrovascular incidents * Current tobacco use

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Motor Activity type 1 diabetes mellitus

As listed by the trial registrant

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

Hypoglycemia associated autonomic failure Type 1 diabetes

Contacts and locations

Locations

  • University of Maryland, Baltimore

    Baltimore, Maryland, 21201, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.