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:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-25 @ 4:54 AM
NCT ID:
NCT02755818
Eligibility Criteria:
Inclusion Criteria:
* self report of stable body weight during the past six months;
* BMI 18-40 kg/m2; Hemodialysis dependent for at least 3 months, prevalent ESRD (end stage renal disease) cohort;
* GFR \> 15 \< 44 ml/min (CKD cohort);
* GFR \> 60 ml/min (Control cohort).
Exclusion Criteria:
* Diabetes Mellitus (American Diabetes Association definition: fasting glucose \>120 mg/dl);
* Evidence of liver disorder, ie; hepatitis
* Evidence of thyroid disorders
* HIV by medical history (HIV test will not be performed)
* Renal transplant recipient
* Oral contraceptive/ hormone replacement therapy
* Systemic use of systemic or inhaled corticosteroids in the past month
* Contraindication to systemic anticoagulation (heparin administration is necessary to measure levels of LPL, HL);
* Hemoglobin \< 8.5 g/dl (anemia);
* Current, within 2 months use of any hypolipidemic or anti-diabetic agents;
* Patients treated with a fibric acid derivative or niacin in the past 4 weeks;
* Urinary protein excretion of greater than 0.5 grams per day;
* Any other condition that, in the opinion of the investigators, would put the subject at risk.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02755818
Study Brief:
Protocol Section:
NCT02755818