An observational study in Obesity and Insulin Resistance, sponsored by University of California, Davis. Terminated. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-23.
Sponsored by University of California, Davis · Observational
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.
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.
1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.
This study's enrollment of 50 is below the median of 80 across 339 observational studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.
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This is a single center cross sectional study of renal failure in comparison to control subjects. This is not a treatment or outcome trial.
Exclusion Criteria:
heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of greater than 60
Drug: Heparin
heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of 30-45
Drug: Heparin
heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of 15-30
Drug: Heparin
heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of less than 15, or on hemodialysis
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
Also known as: Heparin Sodium
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"
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"
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"
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"
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"
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"
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"
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.
| Milestone | Control | Chronic Renal Disease (CKD3b) | Chronic Renal Disease (CKD4) | Chronic Renal Disease (CKD5) |
|---|---|---|---|---|
| Started | 30 | 2 | 2 | 17 |
| Completed | 30 | 2 | 1 | 14 |
| Not completed | 0 | 0 | 1 | 3 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 2 |
| Withdrew: Withdrawal by pi | 0 | 0 | 1 | 1 |
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.
| mg/dL | Control | Chronic Kidney Disease, Stage 5 (CKD5) | Chronic Kidney Disease 4 (CKD4) | Chronic Kidney Disease Stage 3b (CKD 3b) |
|---|---|---|---|---|
| HDL (High Density Lipoprotein) Level in Control and Chronic Kidney Disease (CKD 3b, 4, 5) Groups | 46.77 ± 14.88 | 38.79 ± 11.9 | 71 ± NA | 43.50 ± 9.19 |
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.
| mg/dL | Control | Chronic Kidney Disease, Stage 5 (CKD5) | Chronic Kidney Disease, Stage 4 (CKD4) | Chronic Kidney Disease, Stage 3b (CKD3b) |
|---|---|---|---|---|
| LDL Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups | 105.93 ± 28.03 | 75.29 ± 25.17 | 235 ± NA | 112.50 ± 30.41 |
C-reactive protein (CRP) is an inflammation marker produced by the liver. An increase in CRP value may means inflammation in the body.
| mg/dL | Control | Chronic Kidney Disease, Stage 5 (CKD5) | Chronic Kidney Disease, Stage 4 (CKD4) | Chronic Kidney Disease, Stage 3b (CKD3b) |
|---|---|---|---|---|
| C Reactive Protein (CRP) Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups | 0.26 ± 0.17 | 0.74 ± 0.64 | 1.6 ± NA | 0.25 ± 0.07 |
Body Mass Index (BMI) is calculated from subject's weight (kilogram) and height (meter)
| kg/m2 | Control | Chronic Kidney Disease, Stage 5 (CKD5) | Chronic Kidney Disease, Stage 4 (CKD4) | Chronic Kidney Disease, Stage 3b (CKD3b) |
|---|---|---|---|---|
| Body Mass Index (BMI) in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups | 25.72 ± 4.42 | 29.51 ± 5.91 | 32.87 ± 6.01 | 26.83 ± 5.07 |
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.
| uU/mL | Control | Chronic Kidney Disease, Stage 5 (CKD5) | Chronic Kidney Disease, Stage 4 (CKD4) | Chronic Kidney Disease, Stage 3b (CKD3b) |
|---|---|---|---|---|
| Insulin Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups | 8.52 ± 5.74 | 8.02 ± 6.01 | 8.3 ± NA | 4.9 ± 1.56 |
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
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | — | — | — |
| Chronic Renal Disease (CKD3b) | — | — | — |
| Chronic Renal Disease (CKD4) | — | — | — |
| Chronic Renal Disease (CKD5) | — | — | — |
Non-diabetic
| Age, Categorical(Participants) | Control | Chronic Renal Disease (CKD3b) | Chronic Renal Disease (CKD4) | Chronic Renal Disease (CKD5) | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 30 | 0 | 2 | 17 | 49 |
| >=65 years | 0 | 2 | 0 | 0 | 2 |
| Sex: Female, Male(Participants) | Control | Chronic Renal Disease (CKD3b) | Chronic Renal Disease (CKD4) | Chronic Renal Disease (CKD5) | Total |
|---|---|---|---|---|---|
| Female | 16 | 0 | 2 | 3 | 21 |
| Male | 14 | 2 | 0 | 14 | 30 |
| Race/Ethnicity, Customized(Participants) | Control | Chronic Renal Disease (CKD3b) | Chronic Renal Disease (CKD4) | Chronic Renal Disease (CKD5) | Total |
|---|---|---|---|---|---|
| Asian | 5 | 1 | 0 | 0 | 6 |
| African American | 3 | 0 | 1 | 8 | 12 |
| Hispanic | 6 | 0 | 0 | 3 | 9 |
| Non-Hispanic | 15 | 1 | 1 | 6 | 23 |
| Other | 1 | 0 | 0 | 0 | 1 |
No study locations are listed for this record.
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Plan to share: Yes — once published; data will be shared
Supporting information: Sap, Icf
This study is terminated, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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University of California, Davis