The Effects of Fluoxetine and/or DHEA

NCT ID: NCT03228732

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-19
• Study Completion Date: 2026-12-15

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

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

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

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

Fluoxetine

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

DHEA

Intervention Type: DRUG

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

Fluoxetine and 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 fluoxetine and DHEA

Visit 2:

same as visit 1

Group Type: ACTIVE_COMPARATOR

Fluoxetine and DHEA

Intervention Type: DRUG

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

Interventions

Placebo Oral Tablet

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

Intervention Type: DRUG

Placebo Oral Tablet

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

Intervention Type: DRUG

Fluoxetine

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

Intervention Type: DRUG

DHEA

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

Intervention Type: DRUG

Fluoxetine and DHEA

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

Intervention Type: DRUG

Other Intervention Names

dehydroepiandrosterone; Prozac, dehydroepiandrosterone

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Stephen N. Davis, MBBS

Chairman of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen N Davis, MBBS

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

University of Maryland

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Maka Siamashvili, MD

Role: CONTACT

msiamashvili@som.umaryland.edu

410-706-5623

Vanessa Briscoe, PhD

Role: CONTACT

vbriscoe@som.umaryland.edu

Facility Contacts

Maka Siamashvili, MD

Role: primary

msiamashvili@som.umaryland.edu

410-706-5623

Other Identifiers

HP-00075896

Identifier Type: -

Identifier Source: org_study_id