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

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ClinicalTrials.gov Identifier: NCT02755818
Recruitment Status : Enrolling by invitation
First Posted : April 29, 2016
Last Update Posted : November 1, 2017
Sponsor:
Collaborator:
Dialysis Clinic, Inc.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Obesity Insulin Resistance Drug: Heparin

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.

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Independent Effect of Level of Kidney Function and Body Composition On Establishing HDL Cholesterol Levels
Study Start Date : October 2008
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
control
heparin at 50unit/kg of body weight
Drug: Heparin
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
Other Name: Heparin Sodium

chronic renal disease (CKD)
heparin at 50unit/kg of body weight
Drug: Heparin
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
Other Name: Heparin Sodium




Primary Outcome Measures :
  1. Continuous relationship between body composition, insulin resistance, GFR (glomerular filtration rate) and HDL (high density lipoprotein) level in a group of 60 chronic kidney disease subjects and 30 healthy controls [ Time Frame: baseline ]
    Baseline measurements will be collected and compiled for cross sectional study analysis. This is done once all group is completed. Each patient is analyzed only once --termed "baseline". Renal function (such as creatinine) and fasting glucose level is evaluated to measure insulin resistance. Baseline lipid panel will include high density lipoprotein (HDL), low density lipoprotein (LDL), cholesterol, and triglyceride. Dual energy X-ray analysis (DEXA) and bioimpedance spectroscopy (BIS) will result in fat free tissue mass measurement and analysis.


Biospecimen Retention:   Samples Without DNA
whole blood taken separated into plasma, serum, and red cells


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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; 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02755818


Sponsors and Collaborators
University of California, Davis
Dialysis Clinic, Inc.
Investigators
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Principal Investigator: George A Kaysen, MD PhD University of California, Davis
Study Director: Tjien Dwyer, BS University of California, Davis

Additional Information:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
for a copy of Approved Consent Form-please contact Study Coordinator -Tjien Dwyer at tlthio@ucdavis.edu

Publications of Results:
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02755818     History of Changes
Other Study ID Numbers: 220939
First Posted: April 29, 2016    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: once published data will be shared

Keywords provided by University of California, Davis:
high density lipoprotein (HDL)
lipid
insulin resistance
glomerular filtration rate (GFR)
obesity

Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Heparin
Calcium heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action