The Effects of Fluoxetine And/or DHEA

Launched by UNIVERSITY OF MARYLAND, BALTIMORE · Jul 21, 2017

Keywords

ClinConnect Summary

This clinical trial is exploring how two different treatments, fluoxetine (an antidepressant) and dehydroepiandrosterone (DHEA, a hormone), can help people with Type 1 Diabetes manage low blood sugar levels, also known as hypoglycemia. The study aims to find out if these treatments can improve the body's ability to respond to low blood sugar and whether using both together is more effective than using either one alone. About 64 participants between the ages of 18 and 50, who have well-controlled diabetes and no serious complications, will take part in this research.

Participants in the trial will receive either fluoxetine, DHEA, a combination of both, or a placebo (which contains no active medication). Throughout the study, researchers will closely monitor how their bodies respond to low blood sugar while on these treatments. It's important to note that certain health conditions and medications may exclude someone from participating, so potential volunteers should review the eligibility criteria carefully. This study could provide valuable insights into new ways to help people with Type 1 Diabetes manage their condition.

Gender

ALL

Eligibility criteria

• 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