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 @ 9:18 PM
Ignite Modification Date:
2025-12-24 @ 9:18 PM
NCT ID:
NCT01601704
Eligibility Criteria:
Inclusion Criteria:
1. ≥50 years of age (women) or ≥45 years of age (men)
2. Body mass index (BMI) ≥27 kg/m2 and ≤50 kg/m2
3. Waist circumference ≥88 cm (women) or ≥102 cm (men)
4. At increased risk of adverse cardiovascular outcomes:
* Cardiovascular disease (confirmed diagnosis or at high likelihood of cardiovascular disease) with at least one of the following:
* History of documented myocardial infarction \>3 months prior to screening
* History of coronary revascularization
* History of carotid or peripheral revascularization
* Angina with ischemic changes (resting ECG), ECG changes on a graded exercise test (GXT), or positive cardiac imaging study
* Ankle brachial index \<0.9 (by simple palpation) within prior 2 years
* ≥50% stenosis of a coronary, carotid, or lower extremity artery within prior 2 years
AND/OR
* Type 2 diabetes mellitus with at least 2 of the following:
* Hypertension (controlled with or without pharmacotherapy at \<145/95 mm Hg)
* Dyslipidemia requiring pharmacotherapy
* Documented low HDL cholesterol (\<50 mg/dL in women or \<40 mg/dL in men) within prior 12 months
* Current tobacco smoker
Exclusion Criteria:
1. Myocardial infarction within 3 months prior to screening
2. Angina pectoris Grade III or IV as per the Canadian Cardiovascular Society grading scheme
3. Clinical history of cerebrovascular disease (stroke)
4. History of tachyarrhythmia other than sinus tachycardia
5. Planned bariatric surgery, cardiac surgery, or coronary angioplasty
6. History of seizures (including febrile seizures), cranial trauma, or other conditions that predispose the subject to seizures
7. History of mania or current diagnosis of active psychosis, active bulimia or anorexia nervosa (binge eating disorder is not exclusionary)
8. Any condition with life expectancy anticipated to be less than 4 years (e.g., congestive heart failure NYHA Class 3 or 4)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT01601704
Study Brief:
Protocol Section:
NCT01601704