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 @ 3:18 AM
Ignite Modification Date:
2025-12-25 @ 3:18 AM
NCT ID:
NCT02043405
Eligibility Criteria:
Inclusion Criteria:
* Obese men and women with pre-diabetes; (BMI 30-40 kg/m2)
* Ages ranging from 30-60 years old;
* Individuals with:
* impaired fasting glucose (IFG), (between 100-125mg/dl, with post-prandial glucose (\<140 mg/dl 2 hrs after 75g OGTT)
* impaired glucose tolerance (IGT), (normal fasting glucose \<100mg/dl, with post-prandial glucose (\>140 mg/dl 2 hrs after 75g OGTT)
* a combination of the two (IFG/IGT) (both impaired fasting glucose (100-125mg/dl), and impaired glucose tolerance (\>140 mg/dl 2 hrs after 75g OGTT), will be verified using oral glucose tolerance testing at initial screening, and
* Sedentary (\<2 hours/week of planned physical activity).
To increase generalizability, and because each subject serves as their own control, women will be enrolled regardless of menopausal status, use of hormone replacement therapy and oral contraceptives.
Exclusion Criteria:
* Regular exercise more than 2 hours/week,
* medications that could affect glucose,
* lipid metabolism,
* thyroid disease,
* history of lung disease,
* pregnancy,
* active cigarette smoking or exposure to second hand smoke, and
* Severe plasma lipid disorders.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
60 Years
Study:
NCT02043405
Study Brief:
Protocol Section:
NCT02043405