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insufficient patients with CKD willing to be injected with heparin
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| Name | Class |
|---|---|
| Dialysis Clinic, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of greater than 60 |
| |
| chronic renal disease (CKD3b) | heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of 30-45 |
| |
| chronic renal disease (CKD4) | heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of 15-30 |
| |
| chronic renal disease (CKD5) | heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of less than 15, or on hemodialysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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" |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| George A Kaysen, MD PhD | University of California, Davis | Principal Investigator |
| Tjien Dwyer, BS | University of California, Davis | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23689544 | Result | 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. |
| Label | URL |
|---|---|
| Nephron Clin Pract. 2012; 122(0): 127-133. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Informed Consent Form | View IPD |
once published; data will be shared
once published; data will be shared
once published; data will be shared
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Chronic Renal Disease (CKD3b) | heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of 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 |
| FG002 | Chronic Renal Disease (CKD4) | heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of 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 |
| FG003 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Non-diabetic
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Data missing (1) for CKD4 group | Posted | Mean | Standard Deviation | mg/dL | HDL (high density lipoprotein) (mg/dL) -- this is a cross sectional study; only one measurement collected, termed "baseline" |
|
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This is not an interventional study. No adverse event monitored.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| George Kaysen MD - Principal Investigator | University of California, Davis | 916-734-3774 | gakaysen@ucdavis.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 26, 2015 | Apr 30, 2018 | ICF_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jan 19, 2016 | Apr 30, 2018 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 24, 2019 | Apr 26, 2019 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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whole blood taken separated into plasma, serum, and red cells
|
| 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" |
for a copy of Approved Consent Form-please contact Study Coordinator -Tjien Dwyer at tlthio@ucdavis.edu |
| withdrawal by PI |
|
| BG001 |
| 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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Subject has glomerular filtration rate (GFR) of less than 15 cc/min - all subjects are on kidney dialysis |
| OG002 | Chronic Kidney Disease 4 (CKD4) | Subject has glomerular filtration rate (GFR) of 15-29 cc/min |
| OG003 | Chronic Kidney Disease Stage 3b (CKD 3b) | Subject has glomerular filtration rate (GFR) of 30-45 cc/min |
|
|
| 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. | Data missing (1) for CKD4 group | Posted | Mean | Standard Deviation | mg/dL | This is a cross sectional study; only one measurement collected, termed "baseline" |
|
|
|
| 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. | Data missing (1) for CKD4 group | Posted | Mean | Standard Deviation | mg/dL | This is a cross sectional study; only one measurement collected, termed "baseline" |
|
|
|
| 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) | Posted | Mean | Standard Deviation | kg/m2 | This is a cross sectional study; only one measurement collected, termed "baseline" |
|
|
|
| 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. | Data missing (1) for CKD4 and CKD5 group | Posted | Mean | Standard Deviation | uU/mL | This is a cross sectional study; only one measurement collected, termed "baseline" |
|
|
|
| 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 | Data not generated - due to insufficient number of patient recruited in CKD4 and CKD3b for comparison and analysis | Posted | This is a cross sectional study; only one measurement collected, termed "baseline" |
|
|
| 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 | Data not generated - due to insufficient number of patient recruited in CKD4 and CKD3b for comparison and analysis | Posted | This is a cross sectional study; only one measurement collected, termed "baseline" |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Chronic Renal Disease (CKD3b) | heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of 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 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Chronic Renal Disease (CKD4) | heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of 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 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |