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 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT00111358
Eligibility Criteria:
Inclusion Criteria:
* Age greater than or equal to 18 and less than or equal to 65 years of age
* HIV+
* Ability and motivation to modify behavior and make lifestyle changes
* 3 out of 5 of the following:
* Waist circumference greater than 102 cm (40 in) in men and 88 cm (35 in) in women;
* Triglycerides greater than or equal to 150 mg/dL or current anti-lipolytic drug treatment;
* High-density lipoprotein (HDL) less than 40 mg/dL in men and 50 mg/dL in women;
* Blood pressure greater than or equal to 130/85 mmHg or current antihypertensive drug treatment;
* Fasting glucose greater than or equal to 110 mg/dL.
Exclusion Criteria:
* History of unstable angina, aortic stenosis, uncontrolled hypertension, severe neuropathy, arthritis or other contraindication to exercise
* Requiring pharmacological glucocorticoid therapy (\> 7.5mg Prednisone or its equivalent/day)
* Androgen, growth hormone or Megace within 3 months of study initiation. Subjects on a standard dose of testosterone for documented hypogonadism for \> 3 months will be allowed to enter the study.
* New anti-retroviral therapy within 1 month of study initiation
* SGPT \> 5X normal and/or clinically significant liver disease
* Creatinine \> 2.0 mg/dL and/or clinically significant renal disease
* Hemoglobin (Hgb) \< 9 g/dL
* Current drug or alcohol abuse
* History of diabetes mellitus or fasting glucose of greater than or equal to 126 mg/dL
* Current therapy with insulin or other diabetic agent
* Pregnant or actively seeking pregnancy
* Breastfeeding
* Inability to comply with intervention due to lack of motivation, time, social, and/or psychological support
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00111358
Study Brief:
Protocol Section:
NCT00111358