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Fluoxetine and/or DHEA for Type 1 Diabetes Mellitus

This study is investigating how fluoxetine (Prozac), an antidepressant, and DHEA, a natural hormone, might help your body defend against low blood sugar (hypoglycemia) in people with Type 1 Diabetes. Researchers are also looking at the combined effects of fluoxetine and DHEA. You could be eligible if you are 18-50 years old, have Type 1 Diabetes with an HbA1c below 11.0%, and do not have certain diabetes complications or other medical conditions. The study aims to measure changes in certain hormone levels in your blood over an average of three years to see if the treatments are successful. The current status of this study is unclear, and it plans to enroll 60 participants.

Study design
This interventional study plans to enroll 60 participants with Type 1 Diabetes. Participants will receive either placebo, fluoxetine, DHEA, or a combination of fluoxetine and DHEA.
What's involved
You would have two 2-day inpatient visits, with 8 weeks of treatment between these visits. The study measures changes in blood hormone levels over an average of three years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for an average of three years to measure changes in catecholamine levels in plasma.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03228732

The Effects of Fluoxetine and/or DHEA

Recruiting
EARLY_PHASE1Ages 18–50Interventional
University of Maryland, Baltimore
~60 participants
Updated 2025-10-06 on ClinicalTrials.gov
What's tested:Placebo Oral TabletFluoxetineDHEAFluoxetine and DHEA

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in the level of catecholamines in plasma
Measured over An average of 3 years

Conditions

Type 1 Diabetes Mellitus

Explore related trials

Type 1 Diabetes Mellitus

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Stephen N Davis, MBBS · PRINCIPAL_INVESTIGATOR · University of Maryland, Baltimore

Who to contact

Maka Siamashvili, MD
[email protected]
410-706-5623
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

64 (32 males, 32 females) T1DM patients aged 18-50 yr.
HbA1c \< 11.0%
No clinically diagnosed diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc)
Body mass index \< 40kg · m-2

Exclusion

Pregnancy
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 or past history of severe depression, mania or psychotic disease
Subjects that score greater than 50 on the depression scale
Subjects unwillingness or inability to comply with approved contraception measures
Abnormal results following screening tests and physical examination that are clinically significant
Subjects with a history of severe uncontrolled hypertension (i.e., blood pressure greater than 160/100), heart disease, cerebrovascular incidents
Clinically significant cardiac abnormalities (e.g. heart failure, arrhythmias, ischemic tachycardia, S-T segment deviations, etc.) from history or from cardiac stress testing in subjects ≥ 40 years old.
Pneumonia
Hepatic Failure/Jaundice
Creatinine greater than 1.6 mg/dl
Acute Cerebrovascular/ Neurological deficit
Fever greater than 38 °C
Hematocrit lower than 32
WBC lower than 3 thou/ul or greater than 14 thou/ul
Liver Function Tests: SGOT and SGPT greater than twice upper limit of normal range (i.e. greater than 80 U/L).
TBil greater than 2 mg/dl
Alkaline Phosphatase greater than 150U/L
Positive HIV, Hep B, Hep C
Hepatic transaminase \> 2x normal

What this trial measures

  • Change in the level of catecholamines in plasmaAn average of 3 years