Study of the Relationship Between Body Composition, Insulin Resistance and HDL Levels (NCT02755818) | Clinical Trial Compass
TerminatedNot Applicable
Study of the Relationship Between Body Composition, Insulin Resistance and HDL Levels
Stopped: insufficient patients with CKD willing to be injected with heparin
50 participantsStarted 2008-10-22
Plain-language summary
Approximately 20 million people in the United States have some form of kidney failure. People with kidney failure have an increased chance of having low levels of high density lipid (HDL), so called "good cholesterol." Patients who are overweight or obese also have low levels of HDL. The investigators are trying to find out whether causes of low HDL are the same in people who are overweight and in patients with kidney failure so that in the future doctors can better treat low HDL cholesterol levels. People with low levels of HDL are more likely to have heart attacks and strokes and are more likely to lose kidney function. This study hope to learn more about how kidney failure causes low HDL cholesterol levels.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
HDL (High Density Lipoprotein) Level in Control and Chronic Kidney Disease (CKD 3b, 4, 5) Groups
Timeframe: HDL (high density lipoprotein) (mg/dL) -- this is a cross sectional study; only one measurement collected, termed "baseline"
2
LDL Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups
Timeframe: This is a cross sectional study; only one measurement collected, termed "baseline"
3
C Reactive Protein (CRP) Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups
Timeframe: This is a cross sectional study; only one measurement collected, termed "baseline"
4
Body Mass Index (BMI) in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups
Timeframe: This is a cross sectional study; only one measurement collected, termed "baseline"
5
Insulin Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups
Timeframe: This is a cross sectional study; only one measurement collected, termed "baseline"
6
LCAT Activity (Lecithin-Cholesterol Acyltransferase) in Control and Chronic Kidney Disease Groups, Mainly to CKD3b, CKD4