Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005246
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2000-05-25
Brief Title:
Epidemiology of Insulin and Dehydroepiandrosterone Sulfate and Coronary Heart Disease Mortality
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:
2000-05
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 determine whether serum insulin is a risk factor for coronary heart disease morbidity and mortality and whether dehydroepiandrosterone sulfate DHEAS is a risk factor for coronary heart disease mortality Also to ascertain the determinants of serum insulin levels among middle-aged men
Detailed Description:
BACKGROUND
In 1972 the Multiple Risk Factor Intervention Trial began recruiting 12866 men ages 35 to 57 selected for elevation of one or more risk factors but free from coronary heart disease and followed them for an average of seven years after randomization to a risk factor modification group or to a control group referred to their own physicians for treatment The serum from MRFIT had been stored since 1972 Detailed follow-up for the cohort was completed through 1985 and was extended through 1988 using the National Death Index
The role of insulin as a major risk factor for atherosclerosis resurfaced in the 1980s and was the subject of much research at the basic science clinical and epidemiological levels The MRFIT serum data base probably was the only remaining such serum bank in the United States that could test the relationship between insulin levels and coronary heart disease mortality that included detailed measurements of other major cardiovascular risk factors as well as both baseline and two-hour post-load glucose levels in a predominantly non-diabetic population
DHEAS is the most abundant circulating steroid hormone in man and is readily converted to DHEA which is a potent non-competitive inhibitor of glucose-6-phosphate dehydrogenase the rate limiting enzyme of the pentose cycle Several studies suggest a key role of DHEAS in obesity lipid metabolism cellular proliferation and atherosclerosis Barrett-Connor in 1986 reported that low levels of this hormone were a risk factor for cardiovascular disease in men Other studies report that administration of DHEAS to laboratory animals appears to delay aging prevent obesity and lower serum cholesterol levels
DESIGN NARRATIVE
A nested case-control study was conducted using the stored blood serum Laboratory measurements were done blindly without knowledge of whether the specimen was from a case or a control Insulin was measured in all 600 specimens DHEAS was measured in 200 cases and 100 controls The means and distribution of insulin or DHEAS levels were compared between cases and controls The analysis was done separately for the coronary heart disease deaths and surviving myocardial infarction cases and if there were no differences between the case groups they were pooled for comparison with the controls The relationships were determined among the potential confounders coronary heart disease morbidity and mortality and serum insulin or DHEAS levels This analysis also included data on baseline serum cholesterol systolic and diastolic blood pressure cigarette smoking serum thiocyanate HDL and LDL cholesterol triglycerides basal metabolic index fasting and one-hour blood glucose Alcohol intake physical activity pulmonary function and education were also evaluated The relationships among insulin or DHEAS and coronary heart disease morbidity and mortality were evaluated after adjusting for possible confounders
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
In 1972 the Multiple Risk Factor Intervention Trial began recruiting 12866 men ages 35 to 57 selected for elevation of one or more risk factors but free from coronary heart disease and followed them for an average of seven years after randomization to a risk factor modification group or to a control group referred to their own physicians for treatment The serum from MRFIT had been stored since 1972 Detailed follow-up for the cohort was completed through 1985 and was extended through 1988 using the National Death Index
The role of insulin as a major risk factor for atherosclerosis resurfaced in the 1980s and was the subject of much research at the basic science clinical and epidemiological levels The MRFIT serum data base probably was the only remaining such serum bank in the United States that could test the relationship between insulin levels and coronary heart disease mortality that included detailed measurements of other major cardiovascular risk factors as well as both baseline and two-hour post-load glucose levels in a predominantly non-diabetic population
DHEAS is the most abundant circulating steroid hormone in man and is readily converted to DHEA which is a potent non-competitive inhibitor of glucose-6-phosphate dehydrogenase the rate limiting enzyme of the pentose cycle Several studies suggest a key role of DHEAS in obesity lipid metabolism cellular proliferation and atherosclerosis Barrett-Connor in 1986 reported that low levels of this hormone were a risk factor for cardiovascular disease in men Other studies report that administration of DHEAS to laboratory animals appears to delay aging prevent obesity and lower serum cholesterol levels
DESIGN NARRATIVE
A nested case-control study was conducted using the stored blood serum Laboratory measurements were done blindly without knowledge of whether the specimen was from a case or a control Insulin was measured in all 600 specimens DHEAS was measured in 200 cases and 100 controls The means and distribution of insulin or DHEAS levels were compared between cases and controls The analysis was done separately for the coronary heart disease deaths and surviving myocardial infarction cases and if there were no differences between the case groups they were pooled for comparison with the controls The relationships were determined among the potential confounders coronary heart disease morbidity and mortality and serum insulin or DHEAS levels This analysis also included data on baseline serum cholesterol systolic and diastolic blood pressure cigarette smoking serum thiocyanate HDL and LDL cholesterol triglycerides basal metabolic index fasting and one-hour blood glucose Alcohol intake physical activity pulmonary function and education were also evaluated The relationships among insulin or DHEAS and coronary heart disease morbidity and mortality were evaluated after adjusting for possible confounders
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 |
|---|---|---|---|
| R01HL041785 | NIH | None | httpsreporternihgovquickSearchR01HL041785 |