Actively Recruiting
The Effects of Fluoxetine and/or DHEA
Led by University of Maryland, Baltimore · Updated on 2025-10-06
60
Participants Needed
1
Research Sites
469 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
The Effects of Fluoxetine and/or DHEA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 50 years with type 1 diabetes
- HbA1c less than 11.0%
- No clinically diagnosed diabetic tissue complications such as retinopathy, neuropathy, or stasis ulcers
- Body mass index less than 40 kg/m²
You will not qualify if you...
- Pregnancy
- Unable to give voluntary informed consent
- Taking anticoagulant drugs, or having anemia or known bleeding disorders
- Using medications including non-selective beta blockers, sedative-hypnotics, anticonvulsants, antiparkinsonian drugs, antipsychotics, antidepressants, mood stabilizers, CNS stimulants, opioids, or hallucinogens
- Recent medical illness or history of severe depression, mania, or psychotic disease
- Depression scale score greater than 50
- Unwilling or unable to use approved contraception measures
- Clinically significant abnormal results from screening tests or physical exams
- History of severe uncontrolled hypertension (blood pressure over 160/100), heart disease, or cerebrovascular events
- Significant cardiac abnormalities or abnormal cardiac stress test results in participants aged 40 or older
- Pneumonia
- Liver failure or jaundice
- Creatinine level greater than 1.6 mg/dl
- Acute cerebrovascular or neurological deficits
- Fever over 38 °C
- Hematocrit lower than 32
- White blood cell count below 3,000/µl or above 14,000/µl
- Liver function tests (SGOT and SGPT) greater than twice the normal upper limit
- Total bilirubin greater than 2 mg/dl
- Alkaline phosphatase greater than 150 U/L
- Positive test for HIV, Hepatitis B, or Hepatitis C
- Hepatic transaminase levels more than twice normal
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Maryland
Baltimore, Maryland, United States, 21201
Actively Recruiting
Research Team
M
Maka Siamashvili, MD
CONTACT
V
Vanessa Briscoe, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
5
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