Effects of fluoxetine and DHEA on low blood sugar defense in Type 1 Diabetes
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
This study is testing if the medications fluoxetine and DHEA can help people with Type 1 Diabetes better defend against low blood sugar.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT03228732 on ClinicalTrials.gov |
What this trial studies
This study investigates how fluoxetine, a selective serotonin reuptake inhibitor, and dehydroepiandrosterone (DHEA), a naturally occurring hormone, can enhance the body's ability to defend against hypoglycemia in individuals with Type 1 Diabetes Mellitus. Participants will receive either fluoxetine, DHEA, a combination of both, or a placebo, and their responses to low blood glucose levels will be measured. The trial aims to enroll 64 participants aged 18-50, ensuring they meet specific health criteria and do not have complications related to diabetes. The study will help determine the efficacy of these treatments in improving hypoglycemic defense mechanisms.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-50 with Type 1 Diabetes and an HbA1c level below 11.0%.
Not a fit: Patients with a history of severe depression, certain medical conditions, or those on specific medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of hypoglycemia in patients with Type 1 Diabetes, potentially reducing the risk of severe low blood sugar episodes.
How similar studies have performed: While the combination of fluoxetine and DHEA in this context is novel, previous studies have explored the effects of fluoxetine on metabolic processes, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baltimore, Maryland
- University of Maryland — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Stephen N Davis, MBBS — University of Maryland, Baltimore
- Study coordinator: Maka Siamashvili, MD
- Email: msiamashvili@som.umaryland.edu
- Phone: 410-706-5623
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.