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Selective Serotonin Reuptake Inhibitor

Fluoxetine for Type 1 Diabetes

Phase < 1
Recruiting
Led By Stephen N. Davis, MBBS
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
32 (16 males, 16 females) Type 1 diabetic patients aged 18-45 yr.
No clinically diagnosed diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc)
Must not have
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 unable to give voluntary informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during 90 minute experimental period

Summary

This trial will test whether the SSRI fluoxetine can improve SNS responses during exercise in people with Type 1 DM.

Who is the study for?
This trial is for individuals aged 18-45 with Type 1 Diabetes Mellitus (DM), a body mass index under 40kg/m2, and HbA1c levels between 6-10%. Participants should not have diabetic tissue complications like retinopathy or neuropathy. Those with heart disease, hypertension, recent illnesses, on certain medications including antidepressants or anticoagulants, smokers, pregnant women, or unable to consent are excluded.
What is being tested?
The study tests if the drug Fluoxetine (Prozac) can improve the nervous system's response during exercise in people with Type 1 DM who often avoid physical activity due to fear of hypoglycemia. It compares Fluoxetine against a placebo control to see if it can override reduced autonomic responses and sexual dimorphism in exercise-related ANS activity.
What are the potential side effects?
Fluoxetine may cause side effects such as nausea, headaches, sleep disturbances, anxiety and nervousness. Sexual dysfunction and emotional blunting are also possible. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18-45 years old and have Type 1 diabetes.
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I do not have complications from diabetes like eye or nerve issues.
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I have been diagnosed with Type 1 Diabetes.
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I am a healthy individual aged 18-45.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not taking medications like beta blockers, sedatives, or antidepressants.
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I am unable to understand and give consent for my participation.
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I have a history of high blood pressure, heart disease, or strokes.
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I am on blood thinners, have anemia, or a bleeding disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during 90 minute experimental period
This trial's timeline: 3 weeks for screening, Varies for treatment, and during 90 minute experimental period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Catecholamines

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Trial 1-SSRIActive Control1 Intervention
90 minute exercise baseline with 6 weeks treatment with SSRI (Prozac). Repeat 90 minute exercise after 6 week treatment.
Group II: Trial 2-PlaceboPlacebo Group1 Intervention
90 minute exercise at baseline with 6 weeks treatment with placebo. Repeat 90 minute exercise after 6 weeks treatment of placebo.

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
716 Previous Clinical Trials
381,050 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,943 Previous Clinical Trials
47,797,869 Total Patients Enrolled
Stephen N. Davis, MBBSPrincipal Investigator - University of Maryland, Baltimore
University of Maryland, Baltimore

Media Library

Fluoxetine (Selective Serotonin Reuptake Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01672255 — Phase < 1
Type 1 Diabetes Research Study Groups: Trial 1-SSRI, Trial 2-Placebo
Type 1 Diabetes Clinical Trial 2023: Fluoxetine Highlights & Side Effects. Trial Name: NCT01672255 — Phase < 1
Fluoxetine (Selective Serotonin Reuptake Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01672255 — Phase < 1
~3 spots leftby Sep 2025
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