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 @ 9:47 PM
Ignite Modification Date:
2025-12-24 @ 9:47 PM
NCT ID:
NCT04355832
Eligibility Criteria:
Inclusion 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)
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT04355832
Study Brief:
Protocol Section:
NCT04355832