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 @ 2:29 PM
Ignite Modification Date:
2025-12-24 @ 2:29 PM
NCT ID:
NCT02994459
Eligibility Criteria:
Inclusion Criteria:
All subjects
* Age: greater than or equal to 18 years but \<65 years
* Weight stable (i.e., ±2 kg for at least 3 months)
* Sedentary (less than 1 hour of structured exercise per week)
* No evidence of significant organ system dysfunction or disease (e.g., diabetes, impaired kidney function, cancer, etc.)
In addition, subjects must fulfill all of the following inclusion criteria.
Metabolically Normal Lean
* BMI greater than or equal to 18.5 but \<25.0 kg/m2
* Fasting blood glucose: \<100 mg/dl
* Blood glucose 2 h after an OGTT: \<140 mg/dl
* HbA1c \<5.7 %.
Metabolically Normal Obese, likely insulin sensitive
* BMI greater than or equal to 30.0 but \<45.0 kg/m2
* Fasting blood glucose: \<100 mg/dl
* Fasting insulin: \<20 mU/l
* Blood glucose 2 h after an OGTT: \<140 mg/dl
* HbA1c \<5.7 %.
Metabolically Abnormal Obese, likely insulin resistant
* BMI greater than or equal to 30.0 but \<45.0 kg/m2
* Fasting blood glucose ≥100 mg/dl or blood glucose 2 h after an OGTT ≥140 mg/dl or fasting insulin \>20 µU/mL or HbA1c \>5.7 %.
Metabolically Abnormal Lean
* BMI greater than or equal to 18.5 but \<25.0 kg/m2
* Fasting blood glucose ≥100 mg/dl or blood glucose 2 h after an OGTT ≥140 mg/dl or fasting insulin \>20 µU/mL or HbA1c \>5.7 %.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT02994459
Study Brief:
Protocol Section:
NCT02994459