Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility Criteria
- * 40 (20 males, 20 females) individuals with type 1 diabetes aged 18-50 yr.
- * HbA1c \< 11.0%
- * Body mass index \< 40kg • m-2
- * No clinically diagnosed diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc)
- * Subjects unable to give voluntary informed consent
- * Pregnancy
- * 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 unwillingness or inability to comply with approved contraception measures
- * 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
- * Abnormal results following screening tests and physical examination that are clinically significant
- * Acute cerebrovascular/ neurological deficit
- * Fever greater than 38.0 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. \> 80 U/L)
- * TBil \> 2 mg/dl
- * Creatinine \> 1.6 mg/dl
- * Alkaline phosphatase \> 150U/L
- * Hepatic transaminase \> 2x normal
Ages Eligible for Study
18 Years to 50 Years
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
No