Recruiting

Early Phase 1

Fluoxetine & DHEAThe Effects of Fluoxetine and/or DHEA

Sponsor:

University of Maryland, Baltimore

Code:

NCT03228732

Conditions

Type 1 Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Placebo Oral Tablet

Fluoxetine

DHEA

Fluoxetine and DHEA

Study Details

Brief summary:

(1) To determine how the Selective Serotonin Reuptake Inhibitor (SSRI), fluoxetine (Prozac), an antidepressant often used to treat depression, stimulates the participant's body's ability to defend against low blood sugar (hypoglycemia). (2) To learn how a hormone, dehydroepiandrosterone (DHEA), stimulates the participant's body's ability to defend itself from low blood sugar (hypoglycemia). DHEA is a hormone produced naturally in the human body. However, it can be manufactured and is sold as an over-the-counter dietary supplement. The dose the investigators are giving in this study is higher than the usual recommended dosage taken as a supplement for certain medical conditions. (3) To study combined effects of fluoxetine and DHEA during low blood glucose. In the present study, the investigators will measure the participant's body's responses to hypoglycemia when given fluoxetine or DHEA or fluoxetine and DHEA or a placebo (a pill with no fluoxetine or DHEA). Approximately 64 individuals with type 1 diabetes will take part in this study.

Conditions

Type 1 Diabetes Mellitus

Study ID

NCT03228732

Start date

Dec 19, 2017

Status verified date

Sep, 2025

Completion date

Dec 15, 2026

Anticipated

Primary completion date

Sep 15, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

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 Criteria:

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

Screening Laboratory Tests Exclusion Criteria

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

placebo comparator: Placebo 1

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

placebo comparator: Placebo 2

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

active comparator: Fluoxetine

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

active comparator: DHEA

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

active comparator: Fluoxetine and DHEA

Interventions

Placebo Oral Tablet

There will be two 2-day inpatient visits with 8-weeks of treatment with placebo between those visits.

Placebo Oral Tablet

There will be two 2-day inpatient visits with 8-weeks of treatment with placebo between those visits.

Fluoxetine

There will be two 2-day inpatient visits with 8-weeks of treatment with fluoxetine between those visits.

DHEA

There will be two 2-day inpatient visits with 8-weeks of treatment with DHEA between those visits.

Fluoxetine and DHEA

There will be two 2-day inpatient visits with 8-weeks of treatment with fluoxetine and DHEA between those visits.

Primary outcome measure

Change in the level of catecholamines in plasma [ Time Frame: An average of 3 years ]

Central Contacts and Locations

Central contacts

Maka Siamashvili, MD

410-706-5623 msiamashvili@som.umaryland.edu

Vanessa Briscoe, PhD

vbriscoe@som.umaryland.edu

Locations

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Maka Siamashvili, MD

410-706-5623 msiamashvili@som.umaryland.edu

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Oct 6, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2025-10-06.