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Hormone

Fluoxetine + DHEA 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
No clinically diagnosed diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc)
64 (32 males, 32 females) T1DM patients aged 18-50 yr.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up an average of 3 years
Awards & highlights

Study Summary

This trial is testing the effects of the Selective Serotonin Reuptake Inhibitor (SSRI) fluoxetine, an antidepressant often used to treat depression, and the hormone dehydroepiandrosterone (DHEA) on the body's ability to defend against low blood sugar (hypoglycemia). Approximately 64 individuals with type 1 diabetes will take part in this study.

Who is the study for?
This trial is for individuals aged 18-50 with Type 1 Diabetes, without severe diabetic complications or a BMI over 40. Participants should have an HbA1c level below 11.0% and not be on certain medications like antidepressants or beta blockers, among others. They must also not have significant heart issues, uncontrolled hypertension, recent severe illnesses, or psychiatric conditions.Check my eligibility
What is being tested?
The study tests how fluoxetine (an antidepressant), DHEA (a hormone supplement), and their combination affect the body's defense against low blood sugar in people with Type 1 Diabetes compared to a placebo. The goal is to understand if these substances can improve hypoglycemia responses.See study design
What are the potential side effects?
Potential side effects may include those commonly associated with SSRIs like fluoxetine such as nausea, headaches, sleep disturbances and sexual dysfunction; and for DHEA: acne, hair loss, stomach upset and possibly hormonal imbalances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have complications from diabetes like eye or nerve problems.
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I am between 18 and 50 years old with type 1 diabetes.
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I do not have complications from diabetes like eye or nerve problems.
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I am between 18 and 50 years old with type 1 diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~an average of 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and an average of 3 years 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 the level of catecholamines in plasma

Trial Design

5Treatment groups
Active Control
Placebo Group
Group I: FluoxetineActive Control1 Intervention
Visit 1: Study Day 1: Hyperinsulinemia/ hypoglycemia clamp in the AM and PM. Study Day 2: Hyperinsulinemia/ hypoglycemia clamp in the AM only. 8-weeks of treatment with fluoxetine Visit 2: same as visit 1
Group II: DHEAActive Control1 Intervention
Visit 1: Study Day 1: Hyperinsulinemia/ hypoglycemia clamp in the AM and PM. Study Day 2: Hyperinsulinemia/ hypoglycemia clamp in the AM only. 8-weeks of treatment with DHEA Visit 2: same as visit 1
Group III: Fluoxetine and DHEAActive Control1 Intervention
Visit 1: Study Day 1: Hyperinsulinemia/ hypoglycemia clamp in the AM and PM. Study Day 2: Hyperinsulinemia/ hypoglycemia clamp in the AM only. 8-weeks of treatment with fluoxetine and DHEA Visit 2: same as visit 1
Group IV: Placebo 1Placebo Group1 Intervention
Visit 1: Study Day 1: Hyperinsulinemia/ euglycemia clamp in the AM and PM. Study Day 2: Hyperinsulinemia/ hypoglycemia clamp in the AM only. 8-weeks of treatment with placebo Visit 2: same as visit 1
Group V: Placebo 2Placebo Group1 Intervention
Visit 1: Study Day 1: Hyperinsulinemia/ hypoglycemia clamp in the AM and PM. Study Day 2: Hyperinsulinemia/ hypoglycemia clamp in the AM only. 8-weeks of treatment with placebo Visit 2: same as visit 1

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
685 Previous Clinical Trials
373,036 Total Patients Enrolled
Stephen N Davis, MBBSPrincipal InvestigatorUniversity of Maryland, Baltimore
3 Previous Clinical Trials
28 Total Patients Enrolled

Media Library

DHEA (Hormone) Clinical Trial Eligibility Overview. Trial Name: NCT03228732 — Phase < 1
Type 1 Diabetes Research Study Groups: Placebo 1, Placebo 2, Fluoxetine, DHEA, Fluoxetine and DHEA
Type 1 Diabetes Clinical Trial 2023: DHEA Highlights & Side Effects. Trial Name: NCT03228732 — Phase < 1
DHEA (Hormone) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03228732 — Phase < 1
Type 1 Diabetes Patient Testimony for trial: Trial Name: NCT03228732 — Phase < 1

Frequently Asked Questions

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

Do individuals older than 45 years qualify for enrollment in this trial?

"This particular medical trial is seeking individuals between 18 and 50 years old. For those outside of this demographic, there are 157 clinical trials for minors and 190 studies available to participants over 65."

Answered by AI

What medical applications does dehydroepiandrosterone have?

"DHEA is frequently utilized to address myoclonus, and it can also be beneficial in the treatment of unipolar depression, obsessive-compulsive disorder, and anorexia nervosa."

Answered by AI

What are the requirements to partake in this trial?

"This clinical trial is recruiting 60 subjects aged between 18 and 50 who are currently living with diabetes or another autoimmune disorder. Additionally, applicants must satisfy the following criteria: 64 (32 male, 32 female) T1DM patients between ages of 18-50; HbA1c lower than 11%; no evidence of diabetic tissue complications such as retinopathy, neuropathy, stasis ulcers etc.; Body mass index below 40 kg/m2."

Answered by AI

Are participants being sought for this experiment currently?

"In accordance with the clinicaltrials.gov listing, this experiment is recruiting participants. It was originally posted on December 19th 2017 and last modified on April 8th 2022."

Answered by AI

How many individuals have the opportunity to participate in this medical trial?

"Affirmative. Clinicaltrials.gov data confirms that the trial, which was first publicized on December 19th 2017, is actively enrolling participants. The researchers are looking to welcome 60 patients from a single medical site."

Answered by AI

Who else is applying?

What state do they live in?
Kentucky
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I have a bunch of problems with my diabetes type 1.
PatientReceived 1 prior treatment
~7 spots leftby Feb 2025