Study of the Relationship Between Body Composition, Insulin Resistance and HDL Levels

Terminated

• Conditions: Obesity; Insulin Resistance
• Interventions: Drug: Heparin

• Registration Number: NCT02755818
• Lead Sponsor: University of California, Davis

Brief 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.

Detailed Description

This study is not a treatment or outcome trial.This is a single center cross sectional analysis of body composition and lipoprotein level and structure among patients with graded levels of renal failure in comparison to control subjects. To study the relationship between HDL cholesterol and both body composition and insulin resistance measured as homeostatic model assessment (HOMA) among a cohort of non diabetic non-proteinuric patients with advanced chronic kidney disease (CKD) compared to non diabetic subjects having normal kidney function. Renal patients chosen will be with advanced CKD stage 3, Stage 4, and stage 5 - which is end stage renal failure (ESRD) and on hemodialysis. Fasting blood will be taken for the evaluation of baseline lipid and renal function, and blood glucose level to make sure that there is no recent evidence of diabetes. Body compositions will be measured with 2 established methods: DEXA and whole body bio-impedance spectroscopy (BIS). Fat mass and analysis will be estimated so as to provide a relationship between adiposity, insulin resistance, residual renal function and HDL levels and structure.

Study Timeline

• Study Start: 2008-10-22
• Study First Submitted: 2016-03-10
• Study First Submitted QC: 2016-04-28
• Study First Posted: 2016-04-29
• Results First Submitted: 2018-05-03
• Primary Completion: 2019-02-28
• Study Completion: 2019-02-28
• Results First Submitted QC: 2019-04-29
• Results First Posted: 2019-07-17
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-19
• Last Update Posted: 2021-02-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
chronic renal disease (CKD3b)	Heparin	heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of 30-45
control	Heparin	heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of greater than 60
chronic renal disease (CKD5)	Heparin	heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of less than 15, or on hemodialysis
chronic renal disease (CKD4)	Heparin	heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of 15-30

Primary Outcome Measures

Name	Time	Method
LDL Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups	This is a cross sectional study; only one measurement collected, termed "baseline"	LDL (low-density lipoprotein), is a type of cholesterol (fat) circulating in the blood vessels, and can form plaques. High levels of LDL cholesterol may raise your risk for heart disease and stroke.
Body Mass Index (BMI) in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups	This is a cross sectional study; only one measurement collected, termed "baseline"	Body Mass Index (BMI) is calculated from subject's weight (kilogram) and height (meter)
CETP Activity (Lecithin-Cholesterol Acyltransferase) in Control and Chronic Kidney Disease Groups, Mainly to CKD3b, CKD4	This is a cross sectional study; only one measurement collected, termed "baseline"	CETP activity measures the transfers of neutral lipids from high density lipoproteins (HDL) to very low density lipoprotein (VLDL) and low density lipoprotein (LDL). CETP may give us the other clue to lipoprotein metabolism and reverse cholesterol transport pathway; No data collected- no standard deviation calculated
HDL (High Density Lipoprotein) Level in Control and Chronic Kidney Disease (CKD 3b, 4, 5) Groups	HDL (high density lipoprotein) (mg/dL) -- this is a cross sectional study; only one measurement collected, termed "baseline"	HDL (high-density lipoprotein), is called "good" cholesterol. It binds to cholesterols marked for disposal back to the liver to be digested and disposed by the body. High HDL level may lower your risk for heart disease and stroke.
Insulin Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups	This is a cross sectional study; only one measurement collected, termed "baseline"	Insulin is a hormone made by the pancreas that allows the body to use or store sugar (glucose) from the food eaten. Insulin regulates blood sugar level.
C Reactive Protein (CRP) Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups	This is a cross sectional study; only one measurement collected, termed "baseline"	C-reactive protein (CRP) is an inflammation marker produced by the liver. An increase in CRP value may means inflammation in the body.
LCAT Activity (Lecithin-Cholesterol Acyltransferase) in Control and Chronic Kidney Disease Groups, Mainly to CKD3b, CKD4	This is a cross sectional study; only one measurement collected, termed "baseline"	LCAT measures phospholipase activity in plasma. Measuring LCAT activity may be useful in clarifying the aspects of lipid metabolism in relation to reverse cholesterol transport; No data collected- no standard deviation calculated