The Effects of Fluoxetine and/or DHEA

Type 1 Diabetes Mellitus Clinical Trial

Official title:

The Effects of the Selective Serotonin Reuptake Inhibitor, Fluoxetine and/or DHEA, on Neuroendocrine, Autonomic Nervous System and Metabolic Counterregulatory Responses During Repeated Hypoglycemia in T1DM Individuals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03228732
• Other study ID #: HP-00075896
• Status: Recruiting
• Phase: Early Phase 1
• Start date: December 19, 2017
• Est. completion date: December 15, 2026

Study information

• Verified date: March 2024
• Source: University of Maryland, Baltimore
• Contact: Maka Siamashvili, MD
• Phone: 410-706-5623
• Email: msiamashvili[@]som.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 15, 2026
• Est. primary completion date: February 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the level of catecholamines in plasma		An average of 3 years