Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005194
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-05-25
Brief Title:
Insulin and Biogenic Amines in Cardiovascular Disease
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:
2000-06
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 the role played by insulin and biogenic amines in obesity-related hypertension and cardiovascular disease
Detailed Description:
BACKGROUND
The Normative Aging Study NAS is a multidisciplinary longitudinal study of aging established by the Veterans Adminstration in 1963 Six thousand male volunteers from the Greater Boston area were screened for acceptance into the study according to laboratory clinical radiologic and electrocardiographic criteria Volunteers who had a history or presence of such chronic conditions as heart disease diabetes cancer peptic ulcer gout or recurrent asthma bronchitis or sinusitis were not admitted to the study Also disqualified were those with either systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg Acceptable conditions included childhood diseases such as rheumatic fever or kidney infection that had not precluded prior military service as well as hepatitis malaria jaundice or anemia so long as no sequelae were present and functions were intact Eventually 2280 men were accepted into the NAS ranging in age from 21-81 years with a mean of 42 years Participants were enrolled and received their first medical examination between 1963 and 1968 Subsequently men 51 years of age or under have reported for medical examinations every five years After age 51 they have reported every three years In 1986 A total of 1894 subjects remained under active observation with 756 or 332 percent being over age 65 The study tested the hypothesis that dietary intake and genetic factors predispose to the development of obesity Obesity particularly abdominal obesity characterized by a high waisthip ratio is associated with insulin resistance and hyperinsulinemia The hyperinsulinemia stimulates the sympathetic nervous system and influences the peripheral dopaminergic and serotoninergic systems with the development of hypertension and coincident cardiovascular disease The study was funded as a result of a Request for Applications for Research in Nutrition and Cardiovascular Disease released in 1986
DESIGN NARRATIVE
There were three studies In the first study the entire 1894 subjects of the Normative Aging Study of the Veterans Administration were used The study was a cross-sectional and longitudinal investigation of the influence of diet and obesity on the production of hyperinsulinism and increased levels of catecholamines and the relationship of these intermediate outcomes to cardiovascular end points namely postural change in blood pressure and occurrence of myocardial infarction Subsets of subjects from the upper and lower quartiles of body mass index and from the upper and lower quartiles of waisthip ratios were used in the second and third studies
The second study was cross-sectional and explored the interactions of insulin resistance sympathetic nervous system activity and cardiovascular function in 80 individuals
The third study was also cross-sectional and using the same stratified subsets of subjects characterized nutrient effects on renal function particularly sodium excretion and renal amine production
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 Normative Aging Study NAS is a multidisciplinary longitudinal study of aging established by the Veterans Adminstration in 1963 Six thousand male volunteers from the Greater Boston area were screened for acceptance into the study according to laboratory clinical radiologic and electrocardiographic criteria Volunteers who had a history or presence of such chronic conditions as heart disease diabetes cancer peptic ulcer gout or recurrent asthma bronchitis or sinusitis were not admitted to the study Also disqualified were those with either systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg Acceptable conditions included childhood diseases such as rheumatic fever or kidney infection that had not precluded prior military service as well as hepatitis malaria jaundice or anemia so long as no sequelae were present and functions were intact Eventually 2280 men were accepted into the NAS ranging in age from 21-81 years with a mean of 42 years Participants were enrolled and received their first medical examination between 1963 and 1968 Subsequently men 51 years of age or under have reported for medical examinations every five years After age 51 they have reported every three years In 1986 A total of 1894 subjects remained under active observation with 756 or 332 percent being over age 65 The study tested the hypothesis that dietary intake and genetic factors predispose to the development of obesity Obesity particularly abdominal obesity characterized by a high waisthip ratio is associated with insulin resistance and hyperinsulinemia The hyperinsulinemia stimulates the sympathetic nervous system and influences the peripheral dopaminergic and serotoninergic systems with the development of hypertension and coincident cardiovascular disease The study was funded as a result of a Request for Applications for Research in Nutrition and Cardiovascular Disease released in 1986
DESIGN NARRATIVE
There were three studies In the first study the entire 1894 subjects of the Normative Aging Study of the Veterans Administration were used The study was a cross-sectional and longitudinal investigation of the influence of diet and obesity on the production of hyperinsulinism and increased levels of catecholamines and the relationship of these intermediate outcomes to cardiovascular end points namely postural change in blood pressure and occurrence of myocardial infarction Subsets of subjects from the upper and lower quartiles of body mass index and from the upper and lower quartiles of waisthip ratios were used in the second and third studies
The second study was cross-sectional and explored the interactions of insulin resistance sympathetic nervous system activity and cardiovascular function in 80 individuals
The third study was also cross-sectional and using the same stratified subsets of subjects characterized nutrient effects on renal function particularly sodium excretion and renal amine production
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 |
|---|---|---|---|
| R01HL037871 | NIH | None | httpsreporternihgovquickSearchR01HL037871 |