Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2026-01-28 @ 8:14 PM
Study NCT ID:
NCT02755818
Status:
TERMINATED
Last Update Posted:
2021-02-23
First Post:
2016-03-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of the Relationship Between Body Composition, Insulin Resistance and HDL Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006493', 'term': 'Heparin'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gakaysen@ucdavis.edu', 'phone': '916-734-3774', 'title': 'George Kaysen MD - Principal Investigator', 'organization': 'University of California, Davis'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Early termination of study due to low number of enrollment in chronic kidney disease group 3b and 4.\n\nSecondly, chronic kidney disease subjects prefer not to receive heparin. Heparin is necessary for our study.'}}, 'adverseEventsModule': {'description': 'This is not an interventional study. No adverse event monitored.', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of greater than 60\n\nHeparin: 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', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Chronic Renal Disease (CKD3b)', 'description': 'heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of 30-45\n\nHeparin: 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', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Chronic Renal Disease (CKD4)', 'description': 'heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of 15-30\n\nHeparin: 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', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Chronic Renal Disease (CKD5)', 'description': 'heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of less than 15, or on hemodialysis\n\nHeparin: 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', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'HDL (High Density Lipoprotein) Level in Control and Chronic Kidney Disease (CKD 3b, 4, 5) Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Subject has glomerular filtration rate (GFR) of greater than 60 cc/min -- indication of normal kidney'}, {'id': 'OG001', 'title': 'Chronic Kidney Disease, Stage 5 (CKD5)', 'description': 'Subject has glomerular filtration rate (GFR) of less than 15 cc/min - all subjects are on kidney dialysis'}, {'id': 'OG002', 'title': 'Chronic Kidney Disease 4 (CKD4)', 'description': 'Subject has glomerular filtration rate (GFR) of 15-29 cc/min'}, {'id': 'OG003', 'title': 'Chronic Kidney Disease Stage 3b (CKD 3b)', 'description': 'Subject has glomerular filtration rate (GFR) of 30-45 cc/min'}], 'classes': [{'categories': [{'measurements': [{'value': '46.77', 'spread': '14.88', 'groupId': 'OG000'}, {'value': '38.79', 'spread': '11.9', 'groupId': 'OG001'}, {'value': '71', 'spread': 'NA', 'comment': 'only 1 participant - standard deviation not calculated', 'groupId': 'OG002'}, {'value': '43.50', 'spread': '9.19', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'HDL (high density lipoprotein) (mg/dL) -- this is a cross sectional study; only one measurement collected, termed "baseline"', 'description': '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.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data missing (1) for CKD4 group'}, {'type': 'PRIMARY', 'title': 'LDL Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Subject has glomerular filtration rate (GFR) of greater than 60 cc/min -- indication of normal kidney'}, {'id': 'OG001', 'title': 'Chronic Kidney Disease, Stage 5 (CKD5)', 'description': 'Subject has glomerular filtration rate (GFR) of less than 15 cc/min - all subjects are on kidney dialysis'}, {'id': 'OG002', 'title': 'Chronic Kidney Disease, Stage 4 (CKD4)', 'description': 'Subject has glomerular filtration rate (GFR) of 15-29 cc/min - subject has severe kidney disease'}, {'id': 'OG003', 'title': 'Chronic Kidney Disease, Stage 3b (CKD3b)', 'description': 'Subject has glomerular filtration rate (GFR) of 30-44 cc/min - subject has markedly reduced kidney function'}], 'classes': [{'categories': [{'measurements': [{'value': '105.93', 'spread': '28.03', 'groupId': 'OG000'}, {'value': '75.29', 'spread': '25.17', 'groupId': 'OG001'}, {'value': '235', 'spread': 'NA', 'comment': 'one patient only- no standard deviation calculated', 'groupId': 'OG002'}, {'value': '112.50', 'spread': '30.41', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'This is a cross sectional study; only one measurement collected, termed "baseline"', 'description': '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.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data missing (1) for CKD4 group'}, {'type': 'PRIMARY', 'title': 'C Reactive Protein (CRP) Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Subject has glomerular filtration rate (GFR) of greater than 60 cc/min -- indication of normal kidney'}, {'id': 'OG001', 'title': 'Chronic Kidney Disease, Stage 5 (CKD5)', 'description': 'Subject has glomerular filtration rate (GFR) of less than 15 cc/min - all subjects are on kidney dialysis'}, {'id': 'OG002', 'title': 'Chronic Kidney Disease, Stage 4 (CKD4)', 'description': 'Subject has glomerular filtration rate (GFR) of 15-29 cc/min - subject has severe kidney disease'}, {'id': 'OG003', 'title': 'Chronic Kidney Disease, Stage 3b (CKD3b)', 'description': 'Subject has glomerular filtration rate (GFR) of 30-44 cc/min - subject has markedly reduced kidney function'}], 'classes': [{'categories': [{'measurements': [{'value': '0.26', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '0.74', 'spread': '0.64', 'groupId': 'OG001'}, {'value': '1.6', 'spread': 'NA', 'comment': 'one patient only- no standard deviation calculated', 'groupId': 'OG002'}, {'value': '0.25', 'spread': '0.07', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'This is a cross sectional study; only one measurement collected, termed "baseline"', 'description': 'C-reactive protein (CRP) is an inflammation marker produced by the liver. An increase in CRP value may means inflammation in the body.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data missing (1) for CKD4 group'}, {'type': 'PRIMARY', 'title': 'Body Mass Index (BMI) in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Subject has glomerular filtration rate (GFR) of greater than 60 cc/min -- indication of normal kidney'}, {'id': 'OG001', 'title': 'Chronic Kidney Disease, Stage 5 (CKD5)', 'description': 'Subject has glomerular filtration rate (GFR) of less than 15 cc/min - all subjects are on kidney dialysis'}, {'id': 'OG002', 'title': 'Chronic Kidney Disease, Stage 4 (CKD4)', 'description': 'Subject has glomerular filtration rate (GFR) of 15-29 cc/min - subject has severe kidney disease'}, {'id': 'OG003', 'title': 'Chronic Kidney Disease, Stage 3b (CKD3b)', 'description': 'Subject has glomerular filtration rate (GFR) of 30-44 cc/min - subject has markedly reduced kidney function'}], 'classes': [{'categories': [{'measurements': [{'value': '25.72', 'spread': '4.42', 'groupId': 'OG000'}, {'value': '29.51', 'spread': '5.91', 'groupId': 'OG001'}, {'value': '32.87', 'spread': '6.01', 'groupId': 'OG002'}, {'value': '26.83', 'spread': '5.07', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'This is a cross sectional study; only one measurement collected, termed "baseline"', 'description': "Body Mass Index (BMI) is calculated from subject's weight (kilogram) and height (meter)", 'unitOfMeasure': 'kg/m2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Insulin Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Subject has glomerular filtration rate (GFR) of greater than 60 cc/min -- indication of normal kidney'}, {'id': 'OG001', 'title': 'Chronic Kidney Disease, Stage 5 (CKD5)', 'description': 'Subject has glomerular filtration rate (GFR) of less than 15 cc/min - all subjects are on kidney dialysis'}, {'id': 'OG002', 'title': 'Chronic Kidney Disease, Stage 4 (CKD4)', 'description': 'Subject has glomerular filtration rate (GFR) of 15-29 cc/min - subject has severe kidney disease'}, {'id': 'OG003', 'title': 'Chronic Kidney Disease, Stage 3b (CKD3b)', 'description': 'Subject has glomerular filtration rate (GFR) of 30-44 cc/min - subject has markedly reduced kidney function'}], 'classes': [{'categories': [{'measurements': [{'value': '8.52', 'spread': '5.74', 'groupId': 'OG000'}, {'value': '8.02', 'spread': '6.01', 'groupId': 'OG001'}, {'value': '8.3', 'spread': 'NA', 'comment': 'only 1 patient, standard deviation is not calculated', 'groupId': 'OG002'}, {'value': '4.9', 'spread': '1.56', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'This is a cross sectional study; only one measurement collected, termed "baseline"', 'description': '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.', 'unitOfMeasure': 'uU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data missing (1) for CKD4 and CKD5 group'}, {'type': 'PRIMARY', 'title': 'LCAT Activity (Lecithin-Cholesterol Acyltransferase) in Control and Chronic Kidney Disease Groups, Mainly to CKD3b, CKD4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Subject has glomerular filtration rate (GFR) of greater than 60 cc/min -- indication of normal kidney'}, {'id': 'OG001', 'title': 'Chronic Kidney Disease, Stage 5 (CKD5)', 'description': 'Subject has glomerular filtration rate (GFR) of less than 15 cc/min - all subjects are on kidney dialysis'}, {'id': 'OG002', 'title': 'Chronic Kidney Disease, Stage 4 (CKD4)', 'description': 'Subject has glomerular filtration rate (GFR) of 15-29 cc/min - subject has severe kidney disease'}, {'id': 'OG003', 'title': 'Chronic Kidney Disease, Stage 3b (CKD3b)', 'description': 'Subject has glomerular filtration rate (GFR) of 30-44 cc/min - subject has markedly reduced kidney function'}], 'timeFrame': 'This is a cross sectional study; only one measurement collected, termed "baseline"', 'description': '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\n\nNo data collected- no standard deviation calculated', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not generated - due to insufficient number of patient recruited in CKD4 and CKD3b for comparison and analysis'}, {'type': 'PRIMARY', 'title': 'CETP Activity (Lecithin-Cholesterol Acyltransferase) in Control and Chronic Kidney Disease Groups, Mainly to CKD3b, CKD4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Subject has glomerular filtration rate (GFR) of greater than 60 cc/min -- indication of normal kidney'}, {'id': 'OG001', 'title': 'Chronic Kidney Disease, Stage 5 (CKD5)', 'description': 'Subject has glomerular filtration rate (GFR) of less than 15 cc/min - all subjects are on kidney dialysis'}, {'id': 'OG002', 'title': 'Chronic Kidney Disease, Stage 4 (CKD4)', 'description': 'Subject has glomerular filtration rate (GFR) of 15-29 cc/min - subject has severe kidney disease'}, {'id': 'OG003', 'title': 'Chronic Kidney Disease, Stage 3b (CKD3b)', 'description': 'Subject has glomerular filtration rate (GFR) of 30-44 cc/min - subject has markedly reduced kidney function'}], 'timeFrame': 'This is a cross sectional study; only one measurement collected, termed "baseline"', 'description': '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\n\nNo data collected- no standard deviation calculated', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not generated - due to insufficient number of patient recruited in CKD4 and CKD3b for comparison and analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of greater than 60\n\nHeparin: 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'}, {'id': 'FG001', 'title': 'Chronic Renal Disease (CKD3b)', 'description': 'heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of 30-45\n\nHeparin: 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'}, {'id': 'FG002', 'title': 'Chronic Renal Disease (CKD4)', 'description': 'heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of 15-30\n\nHeparin: 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'}, {'id': 'FG003', 'title': 'Chronic Renal Disease (CKD5)', 'description': 'heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of less than 15, or on hemodialysis\n\nHeparin: 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'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'withdrawal by PI', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of greater than 60\n\nHeparin: 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'}, {'id': 'BG001', 'title': 'Chronic Renal Disease (CKD3b)', 'description': 'heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of greater than 30-45\n\nHeparin: 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'}, {'id': 'BG002', 'title': 'Chronic Renal Disease (CKD4)', 'description': 'heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of greater than 15-30\n\nHeparin: 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'}, {'id': 'BG003', 'title': 'Chronic Renal Disease (CKD5)', 'description': 'heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of less than 15, or on hemodialysis\n\nHeparin: 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'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}]}, {'title': 'Non-Hispanic', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Non-diabetic'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-10-26', 'size': 491654, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2018-04-30T16:17', 'hasProtocol': False}, {'date': '2016-01-19', 'size': 385142, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-04-30T17:35', 'hasProtocol': True}, {'date': '2019-04-24', 'size': 75376, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-04-26T18:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'whole blood taken separated into plasma, serum, and red cells'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'insufficient patients with CKD willing to be injected with heparin', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-19', 'studyFirstSubmitDate': '2016-03-10', 'resultsFirstSubmitDate': '2018-05-03', 'studyFirstSubmitQcDate': '2016-04-28', 'lastUpdatePostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-29', 'studyFirstPostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HDL (High Density Lipoprotein) Level in Control and Chronic Kidney Disease (CKD 3b, 4, 5) Groups', 'timeFrame': 'HDL (high density lipoprotein) (mg/dL) -- this is a cross sectional study; only one measurement collected, termed "baseline"', 'description': '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.'}, {'measure': 'LDL Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups', 'timeFrame': 'This is a cross sectional study; only one measurement collected, termed "baseline"', 'description': '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.'}, {'measure': 'C Reactive Protein (CRP) Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups', 'timeFrame': 'This is a cross sectional study; only one measurement collected, termed "baseline"', 'description': 'C-reactive protein (CRP) is an inflammation marker produced by the liver. An increase in CRP value may means inflammation in the body.'}, {'measure': 'Body Mass Index (BMI) in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups', 'timeFrame': 'This is a cross sectional study; only one measurement collected, termed "baseline"', 'description': "Body Mass Index (BMI) is calculated from subject's weight (kilogram) and height (meter)"}, {'measure': 'Insulin Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups', 'timeFrame': 'This is a cross sectional study; only one measurement collected, termed "baseline"', 'description': '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.'}, {'measure': 'LCAT Activity (Lecithin-Cholesterol Acyltransferase) in Control and Chronic Kidney Disease Groups, Mainly to CKD3b, CKD4', 'timeFrame': 'This is a cross sectional study; only one measurement collected, termed "baseline"', 'description': '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\n\nNo data collected- no standard deviation calculated'}, {'measure': 'CETP Activity (Lecithin-Cholesterol Acyltransferase) in Control and Chronic Kidney Disease Groups, Mainly to CKD3b, CKD4', 'timeFrame': 'This is a cross sectional study; only one measurement collected, termed "baseline"', 'description': '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\n\nNo data collected- no standard deviation calculated'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['high density lipoprotein (HDL)', 'lipid', 'insulin resistance', 'glomerular filtration rate (GFR)', 'obesity'], 'conditions': ['Obesity', 'Insulin Resistance']}, 'referencesModule': {'availIpds': [{'url': 'https://www.irbnet.org/release/study/overview.do?ctx_id=0&spk_id=855867', 'type': 'Informed Consent Form', 'comment': 'for a copy of Approved Consent Form-please contact Study Coordinator -Tjien Dwyer at tlthio@ucdavis.edu'}], 'references': [{'pmid': '23689544', 'type': 'RESULT', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4353643/', 'label': 'Nephron Clin Pract. 2012; 122(0): 127-133.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This is a single center cross sectional study of renal failure in comparison to control subjects. This is not a treatment or outcome trial.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* self report of stable body weight during the past six months;\n* BMI 18-40 kg/m2; Hemodialysis dependent for at least 3 months, prevalent ESRD (end stage renal disease) cohort;\n* GFR \\> 15 \\< 44 ml/min (CKD cohort);\n* GFR \\> 60 ml/min (Control cohort).\n\nExclusion Criteria:\n\n* Diabetes Mellitus (American Diabetes Association definition: fasting glucose \\>120 mg/dl);\n* Evidence of liver disorder, ie; hepatitis\n* Evidence of thyroid disorders\n* HIV by medical history (HIV test will not be performed)\n* Renal transplant recipient\n* Oral contraceptive/ hormone replacement therapy\n* Systemic use of systemic or inhaled corticosteroids in the past month\n* Contraindication to systemic anticoagulation (heparin administration is necessary to measure levels of LPL, HL);\n* Hemoglobin \\< 8.5 g/dl (anemia);\n* Current, within 2 months use of any hypolipidemic or anti-diabetic agents;\n* Patients treated with a fibric acid derivative or niacin in the past 4 weeks;\n* Urinary protein excretion of greater than 0.5 grams per day;\n* Any other condition that, in the opinion of the investigators, would put the subject at risk.'}, 'identificationModule': {'nctId': 'NCT02755818', 'briefTitle': 'Study of the Relationship Between Body Composition, Insulin Resistance and HDL Levels', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'The Independent Effect of Level of Kidney Function and Body Composition On Establishing HDL Cholesterol Levels', 'orgStudyIdInfo': {'id': '220939'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'control', 'description': 'heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of greater than 60', 'interventionNames': ['Drug: Heparin']}, {'label': 'chronic renal disease (CKD3b)', 'description': 'heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of 30-45', 'interventionNames': ['Drug: Heparin']}, {'label': 'chronic renal disease (CKD4)', 'description': 'heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of 15-30', 'interventionNames': ['Drug: Heparin']}, {'label': 'chronic renal disease (CKD5)', 'description': 'heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of less than 15, or on hemodialysis', 'interventionNames': ['Drug: Heparin']}], 'interventions': [{'name': 'Heparin', 'type': 'DRUG', 'otherNames': ['Heparin Sodium'], 'description': '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', 'armGroupLabels': ['chronic renal disease (CKD3b)', 'chronic renal disease (CKD4)', 'chronic renal disease (CKD5)', 'control']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'George A Kaysen, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}, {'name': 'Tjien Dwyer, BS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of California, Davis'}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP', 'ICF'], 'timeFrame': 'once published; data will be shared', 'ipdSharing': 'YES', 'description': 'once published; data will be shared', 'accessCriteria': 'once published; data will be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dialysis Clinic, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}