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 range18 Years – 75 Years

SexALL

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.

What they're measuring

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"

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"

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"

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"

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"

LCAT Activity (Lecithin-Cholesterol Acyltransferase) in Control and Chronic Kidney Disease Groups, Mainly to CKD3b, CKD4

Timeframe: This is a cross sectional study; only one measurement collected, termed "baseline"

Trial details

NCT IDNCT02755818

SponsorUniversity of California, Davis

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-02-28

Results submitted2018-05-03

View on ClinicalTrials.gov More Obesity trials