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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07479134
Eligibility Criteria:
Inclusion Criteria:
Age between 12 and 70 years.
Ability and willingness to provide informed consent (or assent with parental consent for minors).
Group 1: Individuals diagnosed with pancreatic β cell dysfunction, including but not limited to:
Type 1 Diabetes
Type 2 Diabetes
Maturity Onset Diabetes of the Young (MODY)
Wolfram Syndrome
Pancreatogenic Diabetes
Group 2: Healthy control donors without pancreatic β cell dysfunction.
Pregnant or breastfeeding women may be included if they meet the inclusion criteria.
Exclusion Criteria:
Age below 12 or above 70 years.
Health condition too compromised to allow safe tissue collection (e.g., acute hypoglycemia \<70 mg/dL or hyperglycemia \>140 mg/dL at sampling).
Inability or unwillingness to provide informed consent/assent.
Active malignancy or current cancer treatment.
Known infection with HIV, Hepatitis B, or Hepatitis C.
Use of medications that may interfere with iPSC generation (e.g., high-dose corticosteroids, immunomodulators), unless approved by investigators.
For participants undergoing skin biopsy: bleeding disorders, local skin infection, allergy to anesthetics, or use of anticoagulants.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
70 Years
Study:
NCT07479134
Study Brief:
Protocol Section:
NCT07479134