Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-24 @ 9:44 PM
NCT ID:
NCT03228732
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03228732
Study Brief:
Protocol Section:
NCT03228732