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 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT03582956
Eligibility Criteria:
Inclusion Criteria:
* All Participants:
1. Clinical diagnosis of T1D
2. HbA1c ≤9%
3. Diabetes duration of at least 12 months
Adolescents with T1D:
1. Age 12-16 years
2. BMI \<75th for lean pediatric subjects, \> 85th percentile for overweight/obese pediatric subjects;
3. Tanner stage 2-5
4. Parent able to provide written consent and participant able to provide assent
5. Not meeting MRI safety criteria
6. Claustrophobia that will prevent participation in the MRI
Lean, young adults with T1D:
1. Age 18-24 years
2. BMI 18.5-24.9 kg/m2
3. Able to provide written consent.
Exclusion Criteria:
1. Use of adjunctive diabetes medications
2. Weight loss medications within the past six months
3. Current psychiatric disorders, including eating disorders (DSM-V criteria)
4. Known liver disease other than nonalcoholic hepatic steatosis
5. Females who are pregnant or lactating
6. Anemia or another medical condition that precludes participation in the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
24 Years
Study:
NCT03582956
Study Brief:
Protocol Section:
NCT03582956