Insulin and Biogenic Amines in Cardiovascular Disease

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005194
First received: May 25, 2000
Last updated: February 17, 2016
Last verified: June 2000
  Purpose
To determine the role played by insulin and biogenic amines in obesity-related hypertension and cardiovascular disease.

Condition
Cardiovascular Diseases
Hypertension
Heart Diseases
Obesity
Myocardial Infarction
Insulin Resistance

Study Type: Observational

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 1986
Study Completion Date: August 1991
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, 2,280 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 1,894 subjects remained under active observation with 756 or 33.2 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 waist/hip 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 1,894 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 waist/hip 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.

  Eligibility

Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Krieger DR, Landsberg L: Mechanisms in Obesity-Related Hypertension: The Role of Insulin and Catecholamines. Proceedings of the 2nd Annual Meeting of the American Society for Hypertension, 1987. Am J Hypertens, 1(1):84-90, 1988
Krieger DR, Landsberg L: Neuroendocrine Mechanisms in Obesity-Related Hypertension: The Role of Insulin and Catecholamines. In: Laragh JH, Brenner B, Kaplan N, (Eds), Perspectives in Hypertension: Endocrine Mechanisms in Hypertension. 1989.

ClinicalTrials.gov Identifier: NCT00005194     History of Changes
Other Study ID Numbers: 1073  R01HL037871 
Study First Received: May 25, 2000
Last Updated: February 17, 2016
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Insulin Resistance
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 25, 2016