Trial Outcomes & Findings for Study of the Relationship Between Body Composition, Insulin Resistance and HDL Levels (NCT NCT02755818)
NCT ID: NCT02755818
Last Updated: 2021-02-23
Results Overview
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.
Recruitment status
TERMINATED
Target enrollment
50 participants
Primary outcome timeframe
HDL (high density lipoprotein) (mg/dL) -- this is a cross sectional study; only one measurement collected, termed "baseline"
Results posted on
2021-02-23
Participant Flow
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.
Participant milestones
| Measure |
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
|
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
|
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
|
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
2
|
2
|
17
|
|
Overall Study
COMPLETED
|
30
|
2
|
1
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
3
|
Reasons for withdrawal
| Measure |
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
|
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
|
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
|
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
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
|
Overall Study
withdrawal by PI
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Study of the Relationship Between Body Composition, Insulin Resistance and HDL Levels
Baseline characteristics by cohort
| Measure |
Control
n=30 Participants
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
|
Chronic Renal Disease (CKD3b)
n=2 Participants
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
|
Chronic Renal Disease (CKD4)
n=2 Participants
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
|
Chronic Renal Disease (CKD5)
n=17 Participants
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
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic
|
15 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Control
n=30 Participants
Subject has glomerular filtration rate (GFR) of greater than 60 cc/min -- indication of normal kidney
|
Chronic Kidney Disease, Stage 5 (CKD5)
n=14 Participants
Subject has glomerular filtration rate (GFR) of less than 15 cc/min - all subjects are on kidney dialysis
|
Chronic Kidney Disease 4 (CKD4)
n=1 Participants
Subject has glomerular filtration rate (GFR) of 15-29 cc/min
|
Chronic Kidney Disease Stage 3b (CKD 3b)
n=2 Participants
Subject has glomerular filtration rate (GFR) of 30-45 cc/min
|
|---|---|---|---|---|
|
HDL (High Density Lipoprotein) Level in Control and Chronic Kidney Disease (CKD 3b, 4, 5) Groups
|
46.77 mg/dL
Standard Deviation 14.88
|
38.79 mg/dL
Standard Deviation 11.9
|
71 mg/dL
Standard Deviation NA
only 1 participant - standard deviation not calculated
|
43.50 mg/dL
Standard Deviation 9.19
|
PRIMARY outcome
Timeframe: This is a cross sectional study; only one measurement collected, termed "baseline"Population: Data missing (1) for CKD4 group
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.
Outcome measures
| Measure |
Control
n=30 Participants
Subject has glomerular filtration rate (GFR) of greater than 60 cc/min -- indication of normal kidney
|
Chronic Kidney Disease, Stage 5 (CKD5)
n=14 Participants
Subject has glomerular filtration rate (GFR) of less than 15 cc/min - all subjects are on kidney dialysis
|
Chronic Kidney Disease 4 (CKD4)
n=1 Participants
Subject has glomerular filtration rate (GFR) of 15-29 cc/min
|
Chronic Kidney Disease Stage 3b (CKD 3b)
n=2 Participants
Subject has glomerular filtration rate (GFR) of 30-45 cc/min
|
|---|---|---|---|---|
|
LDL Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups
|
105.93 mg/dL
Standard Deviation 28.03
|
75.29 mg/dL
Standard Deviation 25.17
|
235 mg/dL
Standard Deviation NA
one patient only- no standard deviation calculated
|
112.50 mg/dL
Standard Deviation 30.41
|
PRIMARY outcome
Timeframe: This is a cross sectional study; only one measurement collected, termed "baseline"Population: Data missing (1) for CKD4 group
C-reactive protein (CRP) is an inflammation marker produced by the liver. An increase in CRP value may means inflammation in the body.
Outcome measures
| Measure |
Control
n=30 Participants
Subject has glomerular filtration rate (GFR) of greater than 60 cc/min -- indication of normal kidney
|
Chronic Kidney Disease, Stage 5 (CKD5)
n=14 Participants
Subject has glomerular filtration rate (GFR) of less than 15 cc/min - all subjects are on kidney dialysis
|
Chronic Kidney Disease 4 (CKD4)
n=1 Participants
Subject has glomerular filtration rate (GFR) of 15-29 cc/min
|
Chronic Kidney Disease Stage 3b (CKD 3b)
n=2 Participants
Subject has glomerular filtration rate (GFR) of 30-45 cc/min
|
|---|---|---|---|---|
|
C Reactive Protein (CRP) Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups
|
0.26 mg/dL
Standard Deviation 0.17
|
0.74 mg/dL
Standard Deviation 0.64
|
1.6 mg/dL
Standard Deviation NA
one patient only- no standard deviation calculated
|
0.25 mg/dL
Standard Deviation 0.07
|
PRIMARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Control
n=30 Participants
Subject has glomerular filtration rate (GFR) of greater than 60 cc/min -- indication of normal kidney
|
Chronic Kidney Disease, Stage 5 (CKD5)
n=14 Participants
Subject has glomerular filtration rate (GFR) of less than 15 cc/min - all subjects are on kidney dialysis
|
Chronic Kidney Disease 4 (CKD4)
n=2 Participants
Subject has glomerular filtration rate (GFR) of 15-29 cc/min
|
Chronic Kidney Disease Stage 3b (CKD 3b)
n=2 Participants
Subject has glomerular filtration rate (GFR) of 30-45 cc/min
|
|---|---|---|---|---|
|
Body Mass Index (BMI) in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups
|
25.72 kg/m2
Standard Deviation 4.42
|
29.51 kg/m2
Standard Deviation 5.91
|
32.87 kg/m2
Standard Deviation 6.01
|
26.83 kg/m2
Standard Deviation 5.07
|
PRIMARY outcome
Timeframe: This is a cross sectional study; only one measurement collected, termed "baseline"Population: Data missing (1) for CKD4 and CKD5 group
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.
Outcome measures
| Measure |
Control
n=30 Participants
Subject has glomerular filtration rate (GFR) of greater than 60 cc/min -- indication of normal kidney
|
Chronic Kidney Disease, Stage 5 (CKD5)
n=13 Participants
Subject has glomerular filtration rate (GFR) of less than 15 cc/min - all subjects are on kidney dialysis
|
Chronic Kidney Disease 4 (CKD4)
n=1 Participants
Subject has glomerular filtration rate (GFR) of 15-29 cc/min
|
Chronic Kidney Disease Stage 3b (CKD 3b)
n=2 Participants
Subject has glomerular filtration rate (GFR) of 30-45 cc/min
|
|---|---|---|---|---|
|
Insulin Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups
|
8.52 uU/mL
Standard Deviation 5.74
|
8.02 uU/mL
Standard Deviation 6.01
|
8.3 uU/mL
Standard Deviation NA
only 1 patient, standard deviation is not calculated
|
4.9 uU/mL
Standard Deviation 1.56
|
PRIMARY outcome
Timeframe: 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
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
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 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
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
Outcome measures
Outcome data not reported
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Chronic Renal Disease (CKD3b)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Chronic Renal Disease (CKD4)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Chronic Renal Disease (CKD5)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
George Kaysen MD - Principal Investigator
University of California, Davis
Phone: 916-734-3774
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place