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

NCT02755818 | Terminated Results

• 1 other identifier: 220939
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity; Insulin Resistance

Keywords

high density lipoprotein (HDL); lipid; insulin resistance; glomerular filtration rate (GFR); obesity

Outcome Measures

Primary Outcomes (7)

• HDL (High Density Lipoprotein) Level in Control and Chronic Kidney Disease (CKD 3b, 4, 5) Groups

  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.

  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

  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.

  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

  C-reactive protein (CRP) is an inflammation marker produced by the liver. An increase in CRP value may means inflammation in the body.

  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

  Body Mass Index (BMI) is calculated from subject's weight (kilogram) and height (meter)

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

• Insulin Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups

  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.

  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

  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

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

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

  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

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

Study Arms (4)

control

heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of greater than 60

Drug: Heparin

chronic renal disease (CKD3b)

heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of 30-45

Drug: Heparin

chronic renal disease (CKD4)

heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of 15-30

Drug: Heparin

chronic renal disease (CKD5)

heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of less than 15, or on hemodialysis

Drug: Heparin

Interventions

Heparin DRUG

This is not an interventional study. The investigators use heparin at 50unit/kg of body weight to release enzyme lipoprotein lipase (LPL) from the body. LPL level will be used as part of calculation of lipid analysis and measurements

Also known as: Heparin Sodium

chronic renal disease (CKD3b); chronic renal disease (CKD4); chronic renal disease (CKD5); control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a single center cross sectional study of renal failure in comparison to control subjects. This is not a treatment or outcome trial.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead
• Dialysis Clinic, Inc.: collaborator

Related Publications (1)

• Molfino A, Don BR, Kaysen GA. Comparison of bioimpedance and dual-energy x-ray absorptiometry for measurement of fat mass in hemodialysis patients. Nephron Clin Pract. 2012;122(3-4):127-33. doi: 10.1159/000350817. Epub 2013 May 9.

  PMID: 23689544 RESULT

Related Links

• Nephron Clin Pract. 2012; 122(0): 127-133.

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood taken separated into plasma, serum, and red cells

MeSH Terms

Conditions

Obesity; Insulin Resistance

Interventions

Heparin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Limitations and Caveats

Early termination of study due to low number of enrollment in chronic kidney disease group 3b and 4. Secondly, chronic kidney disease subjects prefer not to receive heparin. Heparin is necessary for our study.

Results Point of Contact

• Title: George Kaysen MD - Principal Investigator
• Organization: University of California, Davis

gakaysen@ucdavis.edu

916-734-3774

Study Officials

• George A Kaysen, MD PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

• Tjien Dwyer, BS

  University of California, Davis

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: April 29, 2016
• Study Start: October 22, 2008
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: February 23, 2021
• Results First Posted: July 17, 2019

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: once published; data will be shared
• Access Criteria: once published; data will be shared