Phase
Condition
Diabetes Mellitus, Type 1
Treatment
Fluoxetine
DHEA
Fluoxetine and DHEA
Clinical Study ID
Ages 18-50 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
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-selectiveBeta 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, maniaor 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 areclinically significant
Subjects with a history of severe uncontrolled hypertension (i.e., blood pressuregreater 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 cardiacstress 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
Study Design
Connect with a study center
University of Maryland
Baltimore, Maryland 21201
United StatesActive - Recruiting
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