The Effects of Fluoxetine And/or DHEA

Last updated: November 1, 2024
Sponsor: University of Maryland, Baltimore
Overall Status: Active - Recruiting

Phase

1

Condition

Diabetes Mellitus, Type 1

Treatment

Fluoxetine

DHEA

Fluoxetine and DHEA

Clinical Study ID

NCT03228732
HP-00075896
  • Ages 18-50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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-selectiveBeta 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, maniaor 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 areclinically significant

  • Subjects with a history of severe uncontrolled hypertension (i.e., blood pressuregreater 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 cardiacstress 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

Total Participants: 60
Treatment Group(s): 4
Primary Treatment: Fluoxetine
Phase: 1
Study Start date:
December 19, 2017
Estimated Completion Date:
December 15, 2026

Connect with a study center

  • University of Maryland

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

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