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:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-25 @ 5:09 AM
NCT ID:
NCT03046927
Eligibility Criteria:
Inclusion Criteria:
1. Age: 10-21 years.
2. Sex: male and female subjects will be enrolled.
3. Tanner stage: I-V.
4. T1D duration of \<3 months (i.e., from first insulin injection) to ensure the inclusion of patients in PCR.
5. Presence of at least one diabetes-associated autoantibody.
6. Normal-weight, overweight-, and obese subjects with T1D
7. Fasting serum C-peptide level of \>0.1 nmol/L (0.3 ng/mL)1; or 2-hour post-meal stimulated C-peptide level of 0.2 nmol/L (≥0.6 ng/mL).
Exclusion Criteria:
1. Subjects on weight altering medications, such as orlistat.
2. Subjects with eating disorders
3. Subjects on medications other than insulin that can affect blood glucose level.
4. Subjects with 25-hydroxyvitamin D \[25(OH)D\] levels of \>70 ng/mL, as this may lead to vitamin D toxicity in the study subjects.
5. Subjects with systemic diseases other than T1D.
6. Subjects with recurrent diabetic ketoacidosis (\>2 episodes since the diagnosis of T1D or in the preceding 3 months); or \>2 episodes of severe hypoglycemia in the preceding 3 mo.
7. Pregnant or breast-feeding female subjects.
8. The receipt of any investigational drug within 6 months prior to this trial.
9. Active malignant neoplasm.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
21 Years
Study:
NCT03046927
Study Brief:
Protocol Section:
NCT03046927