The Effects of Fluoxetine and/or DHEA

NCT03228732 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: HP-00075896
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in the level of catecholamines in plasma

  An average of 3 years

Study Arms (5)

Placebo 1

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

Placebo 2

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

Fluoxetine

ACTIVE COMPARATOR

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

Drug: Fluoxetine

DHEA

ACTIVE COMPARATOR

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

Drug: DHEA

Fluoxetine and DHEA

ACTIVE COMPARATOR

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

Drug: Fluoxetine and DHEA

Interventions

Placebo Oral Tablet DRUG

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

Placebo 1

Fluoxetine DRUG

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

Fluoxetine

DHEA DRUG

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

Also known as: dehydroepiandrosterone

DHEA

Fluoxetine and DHEA DRUG

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

Also known as: Prozac, dehydroepiandrosterone

Fluoxetine and DHEA

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• (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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Fluoxetine; Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Stephen N Davis, MBBS

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maka Siamashvili, MD

CONTACT

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

Vanessa Briscoe, PhD

CONTACT

vbriscoe@som.umaryland.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Medicine

Model Details: Participants will be randomized into 2 groups. Group 1 will consist of a random order of Protocol 1 and Protocol 5. Group 2 will consist of a randomized order of Protocols 2, 3, 4

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 25, 2017
• Study Start: December 19, 2017
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)