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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.

Must not have

Subjects unwillingness or inability to comply with approved contraception measures

Subjects with a history of severe uncontrolled hypertension (i.e., blood pressure greater than 160/100), heart disease, cerebrovascular incidents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable or unwilling to follow the required birth control measures.

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I do not have uncontrolled high blood pressure or a history of severe heart or brain blood vessel problems.

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I am not taking medications like beta blockers, antidepressants, or opioids.

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I do not have liver failure or jaundice.

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I am on blood thinners, have anemia, or a bleeding disorder.

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I do not have serious heart problems.

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I am unable to understand and give consent for my own treatment.

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I have pneumonia.

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I have had a recent stroke or brain injury.

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I have had a fever over 38 °C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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

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

0 / 12Eligibility criteria met