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 @ 2:08 PM
Ignite Modification Date:
2025-12-24 @ 2:08 PM
NCT ID:
NCT04128995
Eligibility Criteria:
Inclusion Criteria for the medical or surgical type 2 diabetes groups
* Age 13-19.9 years of age at time of signing the consent
* Type 2 diabetes by the American Diabetes Association criteria
* Negative diabetes-associated antibodies
Exclusion Criteria for the medical or surgical type 2 diabetes groups Known type 1 diabetes, maturity onset diabetes of the young (MODY), or secondary diabetes
* Any chronic oral steroids use within 60 days of enrollment
* Current pancreatotoxic drugs
* Chronic kidney or liver disease (except NAFLD or DKD)
* Pregnancy, breast-feeding or intension of becoming pregnant
* Prior bariatric surgery
* History of malignancy
* Current participation in another clinical trial that may affect study outcomes
* Other conditions, that in the determination of the study investigator, may interfere with study participation
* Inclusion Criteria for the Obese control group
* Age 13-19.9 years of age at time of signing the consent
* Clinical indication to receive bariatric surgery
Exclusion Criteria for the obese control group
* Known diabetes
* Any chronic oral steroids use within 60 days of enrollment
* Current pancreatotoxic drugs
* Chronic kidney or liver disease (except NAFLD or DKD)
* Pregnancy, breast-feeding or intension of becoming pregnant
* Prior bariatric surgery
* History of malignancy
* Current participation in another clinical trial that may affect study outcomes
* Other conditions, that in the determination of the study investigator, may interfere with study participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
19 Years
Study:
NCT04128995
Study Brief:
Protocol Section:
NCT04128995