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 @ 7:45 PM
Ignite Modification Date:
2025-12-24 @ 7:45 PM
NCT ID:
NCT01435603
Eligibility Criteria:
Inclusion Criteria:
1. 18 years of age or older, AND
2. Body-mass index of ≥ 24 kg/m2, AND
3. Documented Dysglycemia: Either by verification of laboratory test (Fasting Plasma Glucose 100-125 mg/dl OR 2-hour Post-challenge Plasma Glucose 140-199 mg/dl OR A1c 5.7%-10.9%) OR confirmation of Type 2 diabetes mellitus by self-report with verification
Exclusion Criteria (any of the following):
Diseases/Conditions that could limit lifespan and/or increase risk with a lifestyle intervention:
1. Significant cardiovascular disease:
* Uncontrolled hypertension: systolic blood pressure \>180 mmHg or diastolic blood pressure \>105 mmHg
* A1c \> 10.9%
* Heart attack, stroke, or transient ischemic attack (TIA) in the past 6 months
* Chest pain, dizziness, or fainting with physical exertion
2. Lung disease:
* Chronic obstructive airways disease or asthma requiring home oxygen
3. Pregnancy
4. Any other known condition that could limit ability to become physically active or limit life span to \<5 years
Exclusions related to metabolism:
1. Use of medications known to produce hyperglycemia
2. Known disease leading to abnormal glucose metabolism, other than diabetes mellitus, including Cushing's syndrome; acromegaly; pheochromocytoma; chronic pancreatitis
Exclusion for conditions or behaviors likely to affect the conduct of the study:
1. Unable or unwilling to provide informed consent
2. Unable to communicate with the pertinent research study staff
3. Unable to read written English or Spanish
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01435603
Study Brief:
Protocol Section:
NCT01435603