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 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT01357551
Eligibility Criteria:
Inclusion Criteria:
* BMI \>= 30 kg/m2
* Desire to lose weight
* Agrees to attend regular visits per study protocol
* Has a provider at the Durham Veterans Affairs Medical Center
Exclusion Criteria:
* Age \>= 75 years old,
* Most recent serum creatinine \>2.0 mg/dL in men, \>1.7 mg/dL in women),
* Liver disease (cirrhosis, jaundice, or other stigmata of advanced liver disease),
* Type 1 diabetes,
* Hemoglobin A1c \>= 12% in past 6 months
* unstable angina or coronary ischemia workup in past 3 months
* Female: pregnancy, breastfeeding, or lack of birth control if premenopausal
* Transplant recipient
* Pacemaker or defibrillator (bioelectric impedance assessment might interfere with these)
* Average systolic blood pressure in the past year \>= 160 mmHg AND most recent BP \>=160 mmHg
* Dementia, severe psychiatric illness (e.g., major depression), alcohol problem, or illicit substance abuse
* Weight loss of at least 10 lb in previous 3 months
* Enrollment in a weight loss program
* Unable to stand for study measurements
* history of weight loss surgery
* cancer not in remission
* current use of appetite suppressants or weight loss medication
* lack of reliable transportation or telephone
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
74 Years
Study:
NCT01357551
Study Brief:
Protocol Section:
NCT01357551