Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005426
Status:
COMPLETED
Last Update Posted:
2016-02-29
First Post:
2000-05-25
Brief Title:
Effects of CHD Prevention on Lipoprotein Subclasses
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the influence of HDL-subclasses with coronary disease progression and to identify factors influencing HDL subclasses at baseline and over time
Detailed Description:
BACKGROUND
The Stanford Coronary Risk Intervention Project was a four-year randomized clinical trial that showed that risk reduction through lifestyle change and lipid-lowering medications significantly reduced the rate of narrowing of the minimum diameter of coronary artery segments with angiographically visible lesions in 119 patients versus 127 controls who received usual physician care In collaboration with this trial Dr Ronald Krauss measured high-density lipoprotein HDL subclasses by gradient gel electrophoresis HDL may be divided into two HDL2 and three HDL3 subclasses that are approximated by their estimated particle diameters HDL3c 72-78 nm HDL3b 78-82 nm HDL3a 82- 88 nm HDL2a 88-97 nm and HDL2b 97-129 nm The HDL- distribution can also be characterized by the diameter of the predominant peak which may lie in either the HDL3b or HDL3a interval Case control and angiographic studies suggest that coronary heart disease risk is increased when HDL2b is reduced relative to HDL3c and HDL3b See also Study 27
DESIGN NARRATIVE
Using data from the Stanford Coronary Risk Intervention Project SCRIP the following specific questions were examined 1 Did the risk reduction program change specific HDtL subclasses as compared to controls 2 Did the HDL gradient gel profile characterize men most likely to benefit from multifactor risk reduction 3 Did HDL-subclasses change significantly in patients that reduced fat intake reduced body weight or who took one or more of the following medications colestipol nicotinic acid clofibrate probucol gemfibrozil fenofibrate lovastatin guar gum or fish oils 4 What were the cross-sectional associations of HDL-subclasses with adiposity fasting and post-load insulin and glucose diet and medications at baseline Preliminary analyses suggested that 1 During the trial men in the treatment group increased HDL2b 2 the special intervention was most effective in reducing coronary disease progression in subjects with a baseline predominant HDL-peak diameter below the median 3 HDL- subclasses were more strongly influenced by diet and adiposity than by drugs during the trial 4 carbohydrates alcohol and caffeine were associated with specific subclasses at baseline
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
The Stanford Coronary Risk Intervention Project was a four-year randomized clinical trial that showed that risk reduction through lifestyle change and lipid-lowering medications significantly reduced the rate of narrowing of the minimum diameter of coronary artery segments with angiographically visible lesions in 119 patients versus 127 controls who received usual physician care In collaboration with this trial Dr Ronald Krauss measured high-density lipoprotein HDL subclasses by gradient gel electrophoresis HDL may be divided into two HDL2 and three HDL3 subclasses that are approximated by their estimated particle diameters HDL3c 72-78 nm HDL3b 78-82 nm HDL3a 82- 88 nm HDL2a 88-97 nm and HDL2b 97-129 nm The HDL- distribution can also be characterized by the diameter of the predominant peak which may lie in either the HDL3b or HDL3a interval Case control and angiographic studies suggest that coronary heart disease risk is increased when HDL2b is reduced relative to HDL3c and HDL3b See also Study 27
DESIGN NARRATIVE
Using data from the Stanford Coronary Risk Intervention Project SCRIP the following specific questions were examined 1 Did the risk reduction program change specific HDtL subclasses as compared to controls 2 Did the HDL gradient gel profile characterize men most likely to benefit from multifactor risk reduction 3 Did HDL-subclasses change significantly in patients that reduced fat intake reduced body weight or who took one or more of the following medications colestipol nicotinic acid clofibrate probucol gemfibrozil fenofibrate lovastatin guar gum or fish oils 4 What were the cross-sectional associations of HDL-subclasses with adiposity fasting and post-load insulin and glucose diet and medications at baseline Preliminary analyses suggested that 1 During the trial men in the treatment group increased HDL2b 2 the special intervention was most effective in reducing coronary disease progression in subjects with a baseline predominant HDL-peak diameter below the median 3 HDL- subclasses were more strongly influenced by diet and adiposity than by drugs during the trial 4 carbohydrates alcohol and caffeine were associated with specific subclasses at baseline
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R03HL049857 | NIH | None | httpsreporternihgovquickSearchR03HL049857 |