The Effects of Fluoxetine And/or DHEA

University of Maryland Baltimore (UMB)

Status and phase: Enrolling; Early Phase 1

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: DHEA; Drug: Fluoxetine and DHEA; Drug: Placebo Oral Tablet; Drug: Fluoxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT03228732

HP-00075896

Details and patient eligibility

About

(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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 5 patient groups, including a placebo group

Placebo 1

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo Oral Tablet

Drug: Placebo Oral Tablet

Placebo 2

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo Oral Tablet

Drug: Placebo Oral Tablet

Fluoxetine

Active Comparator group

Description:

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

Treatment:

Drug: Fluoxetine

DHEA

Active Comparator group

Description:

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

Treatment:

Drug: DHEA

Fluoxetine and DHEA

Active Comparator group

Description:

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

Treatment:

Drug: Fluoxetine and DHEA