The Effects of Fluoxetine and/or DHEA

Early Phase 1RecruitingNCT03228732

University of Maryland, Baltimore60 enrolled

Overview

(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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Type 1 Diabetes Mellitus

Interventions

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

Placebo Oral TabletDRUG

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

FluoxetineDRUG

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

DHEADRUG

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

Fluoxetine and DHEADRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Maryland

Baltimore, Maryland, United States

RECRUITING

Outcomes

Primary Outcomes

Change in the level of catecholamines in plasma

Time frame: An average of 3 years

Central Contacts

Maka Siamashvili, MD

CONTACT

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

Vanessa Briscoe, PhD

CONTACT

vbriscoe@som.umaryland.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.