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 @ 11:11 PM
Ignite Modification Date:
2025-12-24 @ 11:11 PM
NCT ID:
NCT00581269
Eligibility Criteria:
Inclusion Criteria:
1. Patients with Stage III-IV (estimated GFR 20-59 min/ml) chronic kidney disease measured by MDRD formula.
2. BMI ≥ 30 kg/m2
3. Age \> 18 or \< 65 years.
4. Life expectancy greater than one year.
5. Ability to understand and provide informed consent for participation in the study.
Exclusion Criteria:
1. Active inflammatory disease such as: AIDS (HIV seropositivity is not an exclusion criteria), active hepatitis C or B, active gout, other active inflammatory diseases.
2. Active malignancy excluding basal or squamous cell carcinoma of the skin.
3. Patients suffering from Type I Diabetes Mellitus
4. Patients with reduced daily caloric intake at baseline (≤ 2000 kcal/day) or malnutrition.
5. Patients who are already on a consistent and rigorous exercise regimen.
6. Gastrointestinal dysfunction requiring parental nutrition.
7. History of functional kidney transplant \< 6 months prior to study entry.
8. Anticipated live donor kidney transplant over study duration.
9. Patients taking anti-inflammatory medication except aspirin \< 325mg/day over the past 30 days.
10. Patients taking Vitamin E supplements \> 60 IU/day, vitamin C \> 500mg/day over the past 30days.
11. Patients taking any prednisone therapy.
12. Hospital admission within the last 30 days.
13. On experimental drug protocols.
14. Significant cardiac or vascular disease (symptomatic disease; CV event(s) within the last year; significant occlusive atherosclerotic disease or ischemic disease on non-invasive or invasive diagnostic procedures).
15. Significant physical disability or immobility (joint disease, joint replacement, muscular disorders).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00581269
Study Brief:
Protocol Section:
NCT00581269