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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT02987335
Eligibility Criteria:
Inclusion Criteria:
* Age 19-45 yr
* Diabetes duration at least one year (for the diabetes groups)
* BMI range: 16-22.5 kg/m2 (individuals with lean and type 1 diabetes and non-diabetic controls); 22.5-27 kg/m2 in individuals with type 2 diabetes
* Negative GAD antibodies
* Present (\>1.0pmol/l) C-peptide response to Sustacal challenge
* Stable and moderate-to-poor glycemic control (HbA1c greater than 8%)
* Able and willing to provide informed consent.
Exclusion Criteria:
* Mentally disabled persons
* Major psychiatric disorder on medication (excluding successfully treated depression)
* HIV/AIDS
* History of any cancer
* Alcohol or substance abuse or toxin exposure which could be associated with neuropathy
* Cushing's syndrome
* Pregnancy or breast-feeding
* Untreated or uncontrolled hypertension
* Any Chronic illness requiring medication
* History of bleeding disorder or with a prolonged PT or PTT
* Renal disease
* Liver impairment
* Prisoners
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
45 Years
Study:
NCT02987335
Study Brief:
Protocol Section:
NCT02987335