Insulin Resistance, Obesity
Conditions
Keywords
high density lipoprotein (HDL), lipid, insulin resistance, glomerular filtration rate (GFR), obesity
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.
Interventions
DRUGHeparin
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
Sponsors
Dialysis Clinic, Inc.
University of California, Davis
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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) |
| 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. |
| 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 |
| 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 |
Participant flow
Recruitment details
Subjects are recruited from Sacramento areas within 50 miles radius, and University of California, Davis. Subjects of chronic kidney disease (CKD5) are recruited mainly from five DCI (Dialysis Clinic Incorporation) clinics in Sacramento area.
Participants by arm
| Arm | Count |
|---|---|
| Control heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of greater than 60
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 | 30 |
| Chronic Renal Disease (CKD3b) heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of greater than 30-45
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 | 2 |
| Chronic Renal Disease (CKD4) heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of greater than 15-30
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 | 2 |
| Chronic Renal Disease (CKD5) heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of less than 15, or on hemodialysis
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 | 17 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | withdrawal by PI | 0 | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | Control | Chronic Renal Disease (CKD3b) | Chronic Renal Disease (CKD4) | Chronic Renal Disease (CKD5) | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 0 Participants | 2 Participants | 17 Participants | 49 Participants |
| Race/Ethnicity, Customized African American | 3 Participants | 0 Participants | 1 Participants | 8 Participants | 12 Participants |
| Race/Ethnicity, Customized Asian | 5 Participants | 1 Participants | 0 Participants | 0 Participants | 6 Participants |
| Race/Ethnicity, Customized Hispanic | 6 Participants | 0 Participants | 0 Participants | 3 Participants | 9 Participants |
| Race/Ethnicity, Customized Non-Hispanic | 15 Participants | 1 Participants | 1 Participants | 6 Participants | 23 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 16 Participants | 0 Participants | 2 Participants | 3 Participants | 21 Participants |
| Sex: Female, Male Male | 14 Participants | 2 Participants | 0 Participants | 14 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
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)
Time frame: This is a cross sectional study; only one measurement collected, termed baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Body Mass Index (BMI) in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups | 25.72 kg/m2 | Standard Deviation 4.42 |
| Chronic Kidney Disease, Stage 5 (CKD5) | Body Mass Index (BMI) in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups | 29.51 kg/m2 | Standard Deviation 5.91 |
| Chronic Kidney Disease 4 (CKD4) | Body Mass Index (BMI) in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups | 32.87 kg/m2 | Standard Deviation 6.01 |
| Chronic Kidney Disease Stage 3b (CKD 3b) | Body Mass Index (BMI) in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups | 26.83 kg/m2 | Standard Deviation 5.07 |
Primary
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
Time frame: This is a cross sectional study; only one measurement collected, termed baseline
Population: Data not generated - due to insufficient number of patient recruited in CKD4 and CKD3b for comparison and analysis
Primary
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.
Time frame: This is a cross sectional study; only one measurement collected, termed baseline
Population: Data missing (1) for CKD4 group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | C Reactive Protein (CRP) Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups | 0.26 mg/dL | Standard Deviation 0.17 |
| Chronic Kidney Disease, Stage 5 (CKD5) | C Reactive Protein (CRP) Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups | 0.74 mg/dL | Standard Deviation 0.64 |
| Chronic Kidney Disease 4 (CKD4) | C Reactive Protein (CRP) Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups | 1.6 mg/dL | — |
| Chronic Kidney Disease Stage 3b (CKD 3b) | C Reactive Protein (CRP) Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups | 0.25 mg/dL | Standard Deviation 0.07 |
Primary
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.
Time frame: HDL (high density lipoprotein) (mg/dL) -- this is a cross sectional study; only one measurement collected, termed baseline
Population: Data missing (1) for CKD4 group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | HDL (High Density Lipoprotein) Level in Control and Chronic Kidney Disease (CKD 3b, 4, 5) Groups | 46.77 mg/dL | Standard Deviation 14.88 |
| Chronic Kidney Disease, Stage 5 (CKD5) | HDL (High Density Lipoprotein) Level in Control and Chronic Kidney Disease (CKD 3b, 4, 5) Groups | 38.79 mg/dL | Standard Deviation 11.9 |
| Chronic Kidney Disease 4 (CKD4) | HDL (High Density Lipoprotein) Level in Control and Chronic Kidney Disease (CKD 3b, 4, 5) Groups | 71 mg/dL | — |
| Chronic Kidney Disease Stage 3b (CKD 3b) | HDL (High Density Lipoprotein) Level in Control and Chronic Kidney Disease (CKD 3b, 4, 5) Groups | 43.50 mg/dL | Standard Deviation 9.19 |
Primary
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.
Time frame: This is a cross sectional study; only one measurement collected, termed baseline
Population: Data missing (1) for CKD4 and CKD5 group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Insulin Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups | 8.52 uU/mL | Standard Deviation 5.74 |
| Chronic Kidney Disease, Stage 5 (CKD5) | Insulin Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups | 8.02 uU/mL | Standard Deviation 6.01 |
| Chronic Kidney Disease 4 (CKD4) | Insulin Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups | 8.3 uU/mL | — |
| Chronic Kidney Disease Stage 3b (CKD 3b) | Insulin Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups | 4.9 uU/mL | Standard Deviation 1.56 |
Primary
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
Time frame: This is a cross sectional study; only one measurement collected, termed baseline
Population: Data not generated - due to insufficient number of patient recruited in CKD4 and CKD3b for comparison and analysis
Primary
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.
Time frame: This is a cross sectional study; only one measurement collected, termed baseline
Population: Data missing (1) for CKD4 group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | LDL Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups | 105.93 mg/dL | Standard Deviation 28.03 |
| Chronic Kidney Disease, Stage 5 (CKD5) | LDL Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups | 75.29 mg/dL | Standard Deviation 25.17 |
| Chronic Kidney Disease 4 (CKD4) | LDL Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups | 235 mg/dL | — |
| Chronic Kidney Disease Stage 3b (CKD 3b) | LDL Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups | 112.50 mg/dL | Standard Deviation 30.41 |