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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during 90 minute experimental period
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
687 Previous Clinical Trials
374,582 Total Patients Enrolled
6 Trials studying Hypoglycemia
180 Patients Enrolled for Hypoglycemia
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,832 Previous Clinical Trials
47,306,282 Total Patients Enrolled
6 Trials studying Hypoglycemia
133 Patients Enrolled for Hypoglycemia
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
Hypoglycemia Research Study Groups: Trial 1-SSRI, Trial 2-Placebo
Hypoglycemia 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the purpose of using Trial 1-SSRI?

"myoclonus is often best treated with Trial 1-SSRI. However, this medication can also support patients suffering from unipolar depression, obsessive-compulsive disorder, and anorexia nervosa."

Answered by AI

Are there any restrictions for who is eligible for this clinical trial?

"This clinical trial, which is admitting a total of 64 patients, requires that applicants have hypoglycemia and be between 18-45 years old."

Answered by AI

Does this research include middle-aged adults as participants?

"People between the ages of 18-45 who meet the other requirements set by the researchers conducting this clinical trial are eligible to enroll. There are 244 studies for people over 65 and 174 for people under 18."

Answered by AI

Are there other research trials that have included the use of Trial 1-SSRI?

"At this time, there are a total of 18 ongoing studies involving Trial 1-SSRI. 3 of these studies are currently in Phase 3. Although most of the research is taking place in New Haven, there are 26 locations across the world running similar trials."

Answered by AI

How many people fit the inclusion criteria for this trial?

"Yes, according to the clinicaltrials.gov website, this clinical trial is recruiting patients. The trial was first posted on October 1st, 2012 and was last updated on April 8th, 2022. The study is looking for 64 patients at 1 location."

Answered by AI
~3 spots leftby Dec 2024