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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT04293367
Eligibility Criteria:
Inclusion Criteria:
* African American descent and all four grandparents reported as African Americans
* DNA will also be collected so admixture could be measured post study
* Reported good health (blood work, Hx and PE)
* Non-diabetic (OGTT)
* Pre-menopausal, Age range 20-40 years BMI range of 25-40, with regular menstrual periods
* Sedentary (exercise no more than 2 times/week, for one hour or spend no more than 1000 - 1500 Kcal/wk in physical activity as determined by a Paffenbarger questionnaire).
Exclusion Criteria:
* Any cardiac or pulmonary illnesses which may interfere with their capacity to exercise
* Active smoker
* Consume more than 2 oz. of ethanol/day
* Weight change greater than + 2 kg in the past 3 months
* Currently taking medications or have any physical conditions which may affect insulin action and/or lipid metabolism or have hyperlipidemia (plasma triglyceride greater than or equal to 350 mg/dl or total cholesterol levels greater than or equal to 300 mg/dl).
* Metal implants (ex: pacemaker, implanted jewelry, etc)
* 1st degree family history of type diabetes 2 diabetes (Will be noted but will not constitute an exclusionary criteria).
The subjects' usual diets will be evaluated by the Block 98.2 Food Frequency Questionnaire (BDDS, Berkeley, CA).
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
40 Years
Study:
NCT04293367
Study Brief:
Protocol Section:
NCT04293367