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 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT01050205
Eligibility Criteria:
Inclusion Criteria:
* Screening Eligibility Criteria: Non-diabetic men and women from the specific study sites in the local area who are age 18 years and older at the time of screening with a BMI of at least 25 kg/m2 are eligible for screening.
* Intervention Eligibility Criteria: Individuals attending screening who are found to have prediabetes AND/OR metabolic syndrome are eligible to participate in the intervention. Pre-diabetes is defined as having a fasting glucose \>100 mg/dL and \<126mg/dL. Metabolic syndrome is defined as having at least 3 of the 5 following risk factors:
1. Waist circumference (\>40 inches men, \>35 inches women);
2. Blood pressure \>130 mmHg (systolic) or \>85 mmHg (diastolic) OR history of diagnosed hypertension
3. Low HDL level (\<40mg/dL men, \<50 mg/dL women)
4. Elevated triglyceride level \>150 mg/dL
5. Fasting glucose \>100mg/dL and \<126mg/dL All individuals enrolled in the study should have at least 6th grade reading/writing ability.
Exclusion Criteria:
* Screening Exclusionary Criteria: Women who are currently (or within past 6-weeks) pregnant or lactating, or any individual planning to leave the area before the end of the effort will be considered ineligible to participate in the screening.
* Intervention Exclusionary Criteria: Exclusionary criterion for intervention is the same as for screening. In addition, individuals who are on metformin or are identified as having diabetes as a result of the screening are not eligible. Individuals who have recently (within the past 3 months) initiated or changed their dosage of any blood pressure or lipid medication will also be excluded as being on an unstable regimen will complicate the interpretation of any blood pressure or lipid effects of the intervention.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01050205
Study Brief:
Protocol Section:
NCT01050205