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ObesityNCT02755818

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

An observational study of Obesity and Insulin Resistance, run by University of California, Davis.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Insulin Resistance
What is being tested?
Heparin
How many people
50 participants
Where
No sites listed yet
Study dates
22 Oct 2008to 28 Feb 2019
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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).

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

About this study

Official title: The Independent Effect of Level of Kidney Function and Body Composition On Establishing HDL Cholesterol Levels

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.

Read the 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.

Being tested
Heparin
Keywords
high density lipoprotein (HDL), lipid, insulin resistance, glomerular filtration rate (GFR), obesity
Medical subject headings
Obesity, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HeparinDrug

    Also called Heparin Sodium

    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

Study groups in NCT02755818
Study groupRoleWhat they receive
controlheparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of greater than 60
Receives: Drug: Heparin
chronic renal disease (CKD3b)heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of 30-45
Receives: Drug: Heparin
chronic renal disease (CKD4)heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of 15-30
Receives: 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
Receives: Drug: Heparin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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

    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.

    Measured: 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

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

    Measured: 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

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

    Measured: 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

    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.

    Measured: 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

    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

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

  7. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2016 (estimated)
  2. Study start22 Oct 2008
  3. Primary completion28 Feb 2019
  4. Study completion28 Feb 2019

Why it stopped: insufficient patients with CKD willing to be injected with heparin

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02755818
Sponsor's protocol ID
220939
Status last verified
Feb 2021
First submitted
10 Mar 2016
Last updated
23 Feb 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: once published; data will be shared

Publications

  • 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.

    PubMed 23689544

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Insulin Resistance, run by University of California, Davis.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HDL (High Density Lipoprotein) Level in Control and Chronic Kidney Disease (CKD 3b, 4, 5) Groups (time frame: HDL (high density lipoprotein) (mg/dL) -- this is a cross sectional study; only one measurement collected, termed "baseline"). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02755818, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.

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