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 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT01708694
Eligibility Criteria:
Inclusion Criteria
* Have a body mass index between 30 and 44.9 kg/m2
* Are 35-65 years of age
* Have pre-diabetes, which means impaired fasting glucose (IFG)
* Are willing to complete nutritional and activity questionnaires and 2-3 weeks of baseline testing
* Are willing to enroll in the 3-month intervention and maintain the same level of exercise during the study
* Are willing to maintain weight throughout the study
Exclusion Criteria
* Have evidence of cardiovascular disease, diabetes, symptomatic cholelithiasis (gallstones), or cancer
* Have a fasting blood glucose less than 100 mg/dL or greater than 125 mg/dL
* Have an average screening blood pressure \> 150/100 mm Hg
* Are a pre-menopausal woman but do not have a regular menstrual cycle
* Are pregnant or breastfeeding
* Chronically use medications including diuretics, steroids, and adrenergic-stimulating agents
* Have emotional problems such as clinical depression or other diagnosed psychological conditions
* Use hormonal contraceptives, oral or parenteral glucocorticoids, or any other medication known to influence glucose or insulin homeostasis (balance), within 1 month of study
* Have a clinically significant gastrointestinal malabsorption syndrome, chronic diarrhea, or use antibiotics within one month of study
* Have abnormal laboratory markers (e.g., elevated potassium levels, hemoglobin or hematocrit below the lower limit of normal)
* Chronically consume alcohol (\> 4 servings per day) or actively smoke cigarettes (\> 1/4 pack per day)
* Are on any chronic medication that has not had a stable dose for 1 month or longer
* Are required to perform of any kind of heavy physical activity
* Have metal objects in the body, such as a pacemaker, metal pins, bullet, etc.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
65 Years
Study:
NCT01708694
Study Brief:
Protocol Section:
NCT01708694