NCT03228732RecruitingEarly phase 1
The Effects of Fluoxetine and/or DHEA
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
Source: ClinicalTrials.gov · Last updated 6 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
(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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 20 Jul 2017
- Start date
- 19 Dec 2017
- Primary completion date
- 15 Sept 2026
- Lead sponsor
- University of Maryland, Baltimore
- Diseases
- Type 1 diabetes
- NCT number
- NCT03228732
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 60
- From 19 Dec 2017 to the primary completion date, 15 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Subjects on anticoagulant drugs, anemic or with known bleeding diatheses
- Subjects with a recent medical illness or past history of severe depression, mania or psychotic disease
- Subjects with a history of severe uncontrolled hypertension (i.e., blood pressure greater than 160/100), heart disease, cerebrovascular incidents
- Hepatic Failure/Jaundice
- Positive HIV, Hep B, Hep C
Lab values
- Creatinine greater than 1.6 mg/dl
- Fever greater than 38 °C
- Screening Laboratory Tests Exclusion Criteria
- 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
- Hepatic transaminase \> 2x normal
Age
- 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.
Other
- Pregnancy
- Subjects unable to give voluntary informed consent
- 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
- Pneumonia
- Acute Cerebrovascular/ Neurological deficit
- Hematocrit lower than 32
Who the study is looking for
- 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
Age in the registry: 18 years to 50 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Maryland Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.