Full Text View
Tabular View
No Study Results Posted
Related Studies
Insulin and Biogenic Amines in Cardiovascular Disease
This study has been completed.
First Received: May 25, 2000   Last Updated: June 23, 2005   History of Changes
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00005194
  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

MedlinePlus related topics: Heart Attack Heart Diseases High Blood Pressure Obesity Obesity in Children
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History

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

Study Start Date: September 1986
Estimated 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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:
Landsberg L. Diet, obesity and hypertension: an hypothesis involving insulin, the sympathetic nervous system, and adaptive thermogenesis. Q J Med. 1986 Dec;61(236):1081-90. Review. No abstract available.
Landsberg L. Insulin and hypertension: lessons from obesity. N Engl J Med. 1987 Aug 6;317(6):378-9. No abstract available.
Krieger DR, Landsberg L. Mechanisms in obesity-related hypertension: role of insulin and catecholamines. Am J Hypertens. 1988 Jan;1(1):84-90. Review.
Landsberg L, Krieger DR. Obesity, metabolism, and the sympathetic nervous system. Am J Hypertens. 1989 Mar;2(3 Pt 2):125S-132S. Review.
Landsberg L. Obesity, metabolism, and hypertension. Yale J Biol Med. 1989 Sep-Oct;62(5):511-9. Review.
Troisi RJ, Weiss ST, Segal MR, Cassano PA, Vokonas PS, Landsberg L. The relationship of body fat distribution to blood pressure in normotensive men: the normative aging study. Int J Obes. 1990 Jun;14(6):515-25.
Landsberg L. Insulin resistance, energy balance and sympathetic nervous system activity. Clin Exp Hypertens A. 1990;12(5):817-30. Review.
Landsberg L. The sympathoadrenal system, obesity and hypertension: an overview. J Neurosci Methods. 1990 Sep;34(1-3):179-86. Review.
Sparrow D, O'Connor GT, Young JB, Rosner B, Weiss ST. Relationship of urinary serotonin excretion to cigarette smoking and respiratory symptoms. The Normative Aging Study. Chest. 1992 Apr;101(4):976-80.
Cassano PA, Rosner B, Vokonas PS, Weiss ST. Obesity and body fat distribution in relation to the incidence of non-insulin-dependent diabetes mellitus. A prospective cohort study of men in the normative aging study. Am J Epidemiol. 1992 Dec 15;136(12):1474-86.
Hu H, Sparrow D, Weiss S. Association of serum albumin with blood pressure in the normative aging study. Am J Epidemiol. 1992 Dec 15;136(12):1465-73.
Troisi R, Willett WC, Weiss ST. Trans-fatty acid intake in relation to serum lipid concentrations in adult men. Am J Clin Nutr. 1992 Dec;56(6):1019-24.
Young JB, Troisi RJ, Weiss ST, Parker DR, Sparrow D, Landsberg L. Relationship of catecholamine excretion to body size, obesity, and nutrient intake in middle-aged and elderly men. Am J Clin Nutr. 1992 Nov;56(5):827-34.
Landsberg L, Troisi R, Parker D, Young JB, Weiss ST. Obesity, blood pressure, and the sympathetic nervous system. Ann Epidemiol. 1991 May;1(4):295-303. Review.
Cassano PA, Segal MR, Vokonas PS, Weiss ST. Body fat distribution, blood pressure, and hypertension. A prospective cohort study of men in the normative aging study. Ann Epidemiol. 1990 Oct;1(1):33-48.
Troisi RJ, Heinold JW, Vokonas PS, Weiss ST. Cigarette smoking, dietary intake, and physical activity: effects on body fat distribution--the Normative Aging Study. Am J Clin Nutr. 1991 May;53(5):1104-11.
Troisi RJ, Weiss ST, Parker DR, Sparrow D, Young JB, Landsberg L. Relation of obesity and diet to sympathetic nervous system activity. Hypertension. 1991 May;17(5):669-77.
Landsberg L. Obesity-related hypertension and the insulin resistance syndrome. Trans Am Clin Climatol Assoc. 1994;106:69-75; discussion 75-6. Review. No abstract available.
Landsberg L. Pathophysiology of obesity-related hypertension: role of insulin and the sympathetic nervous system. J Cardiovasc Pharmacol. 1994;23 Suppl 1:S1-8. Review.
Payton M, Hu H, Sparrow D, Weiss ST. Low-level lead exposure and renal function in the Normative Aging Study. Am J Epidemiol. 1994 Nov 1;140(9):821-9.
Ward KD, Sparrow D, Vokonas PS, Willett WC, Landsberg L, Weiss ST. The relationships of abdominal obesity, hyperinsulinemia and saturated fat intake to serum lipid levels: the Normative Aging Study. Int J Obes Relat Metab Disord. 1994 Mar;18(3):137-44.
Ward KD, Sparrow D, Landsberg L, Young JB, Vokonas PS, Weiss ST. The relationship of epinephrine excretion to serum lipid levels: the Normative Aging Study. Metabolism. 1994 Apr;43(4):509-13.
Payton M, Hu H, Sparrow D, Young JB, Landsberg L, Weiss ST. Relation between blood lead and urinary biogenic amines in community-exposed men. Am J Epidemiol. 1993 Nov 15;138(10):815-25.
Landsberg L, Young JB. Sympathoadrenal activity and obesity: physiological rationale for the use of adrenergic thermogenic drugs. Int J Obes Relat Metab Disord. 1993 Feb;17 Suppl 1:S29-34. Review.
Parker DR, Weiss ST, Troisi R, Cassano PA, Vokonas PS, Landsberg L. Relationship of dietary saturated fatty acids and body habitus to serum insulin concentrations: the Normative Aging Study. Am J Clin Nutr. 1993 Aug;58(2):129-36.
Young JB, Macdonald IA. Sympathoadrenal activity in human obesity: heterogeneity of findings since 1980. Int J Obes Relat Metab Disord. 1992 Dec;16(12):959-67. Review.
Landsberg L. Obesity and hypertension: experimental data. J Hypertens Suppl. 1992 Dec;10(7):S195-201.
Daly PA, Landsberg L. Phaeochromocytoma: diagnosis and management. Baillieres Clin Endocrinol Metab. 1992 Jan;6(1):143-66. Review.
Landsberg L. Hyperinsulinemia: possible role in obesity-induced hypertension. Hypertension. 1992 Jan;19(1 Suppl):I61-6. Review.
Daly PA, Landsberg L. Pathogenesis of hypertension in NIDDM: lessons from obesity. J Hum Hypertens. 1991 Aug;5(4):277-85. Review. No abstract available.
Daly PA, Landsberg L. Hypertension in obesity and NIDDM. Role of insulin and sympathetic nervous system. Diabetes Care. 1991 Mar;14(3):240-8. Review.
Manning WJ, Shannon RP, Santinga JA, Parker JA, Gervino EV, Come PC, Wei JY. Reversal of changes in left ventricular diastolic filling associated with normal aging using diltiazem. Am J Cardiol. 1991 Apr 15;67(9):894-6. No abstract available.
Lipsitz LA, Jonsson PV, Marks BL, Parker JA, Royal HD, Wei JY. Reduced supine cardiac volumes and diastolic filling rates in elderly patients with chronic medical conditions. Implications for postural blood pressure homeostasis. J Am Geriatr Soc. 1990 Feb;38(2):103-7.
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.

Study ID Numbers: 1073
Study First Received: May 25, 2000
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00005194     History of Changes
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Obesity
Heart Diseases
Metabolic Diseases
Myocardial Ischemia
Vascular Diseases
Overweight
Ischemia
Insulin
Body Weight
Signs and Symptoms
Hyperinsulinism
Necrosis
Nutrition Disorders
Overnutrition
Insulin Resistance
Infarction
Glucose Metabolism Disorders
Metabolic Disorder
Myocardial Infarction
Hypertension

Additional relevant MeSH terms:
Obesity
Metabolic Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Overweight
Ischemia
Body Weight
Signs and Symptoms
Hyperinsulinism
Necrosis
Pathologic Processes
Nutrition Disorders
Overnutrition
Cardiovascular Diseases
Insulin Resistance
Infarction
Glucose Metabolism Disorders
Myocardial Infarction
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009