Cardiovascular DiseasesNCT00005194
Insulin and Biogenic Amines in Cardiovascular Disease
An observational study of Cardiovascular Diseases and Hypertension, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To determine the role played by insulin and biogenic amines in obesity-related hypertension and cardiovascular disease. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Hypertension, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1986to Aug 1991
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To determine the role played by insulin and biogenic amines in obesity-related hypertension and cardiovascular disease.
Read the 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.
- Conditions
- Cardiovascular Diseases, Hypertension, Heart Diseases, Obesity, Myocardial Infarction, Insulin Resistance
- Medical subject headings
- Cardiovascular Diseases, Hypertension, Heart Diseases, Obesity, Myocardial Infarction, Insulin Resistance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startSep 1986
- Study completionAug 1991
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005194
- Sponsor's protocol ID
- 1073
- Other IDs
- R01HL037871
- Status last verified
- Jun 2000
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
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. No abstract available.
PubMed 3310065Landsberg L. Insulin and hypertension: lessons from obesity. N Engl J Med. 1987 Aug 6;317(6):378-9. doi: 10.1056/NEJM198708063170609. No abstract available.
PubMed 3299098Krieger DR, Landsberg L. Mechanisms in obesity-related hypertension: role of insulin and catecholamines. Am J Hypertens. 1988 Jan;1(1):84-90. doi: 10.1093/ajh/1.1.84.
PubMed 3285861Landsberg L, Krieger DR. Obesity, metabolism, and the sympathetic nervous system. Am J Hypertens. 1989 Mar;2(3 Pt 2):125S-132S. doi: 10.1093/ajh/2.3.125s.
PubMed 2647103Landsberg L. Obesity, metabolism, and hypertension. Yale J Biol Med. 1989 Sep-Oct;62(5):511-9.
PubMed 2697985Troisi 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.
PubMed 2401588Landsberg L. Insulin resistance, energy balance and sympathetic nervous system activity. Clin Exp Hypertens A. 1990;12(5):817-30. doi: 10.3109/10641969009073502.
PubMed 2208753Landsberg L. The sympathoadrenal system, obesity and hypertension: an overview. J Neurosci Methods. 1990 Sep;34(1-3):179-86. doi: 10.1016/0165-0270(90)90056-l.
PubMed 2259240Sparrow 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. doi: 10.1378/chest.101.4.976.
PubMed 1372851Cassano 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. doi: 10.1093/oxfordjournals.aje.a116468.
PubMed 1288277Hu 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. doi: 10.1093/oxfordjournals.aje.a116467.
PubMed 1288276Troisi 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. doi: 10.1093/ajcn/56.6.1019.
PubMed 1442652Young 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. doi: 10.1093/ajcn/56.5.827.
PubMed 1415000Landsberg 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. doi: 10.1016/1047-2797(91)90040-j.
PubMed 1669511Cassano 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. doi: 10.1016/1047-2797(90)90017-m.
PubMed 1669488
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin and Biogenic Amines in Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT00005194
- Acronym / sponsor ID
- 1073
- Conditions
- Cardiovascular Diseases, Hypertension, Heart Diseases, Obesity, Myocardial Infarction, Insulin Resistance
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1986
- Study completion
- Aug 1991 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, 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.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- Background: PubMed 3310065Landsberg 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. No abstract available.
- Background: PubMed 3299098Landsberg L. Insulin and hypertension: lessons from obesity. N Engl J Med. 1987 Aug 6;317(6):378-9. doi: 10.1056/NEJM198708063170609. No abstract available.
- Background: PubMed 3285861Krieger DR, Landsberg L. Mechanisms in obesity-related hypertension: role of insulin and catecholamines. Am J Hypertens. 1988 Jan;1(1):84-90. doi: 10.1093/ajh/1.1.84.
- Background: PubMed 2647103Landsberg L, Krieger DR. Obesity, metabolism, and the sympathetic nervous system. Am J Hypertens. 1989 Mar;2(3 Pt 2):125S-132S. doi: 10.1093/ajh/2.3.125s.
- Background: PubMed 2697985Landsberg L. Obesity, metabolism, and hypertension. Yale J Biol Med. 1989 Sep-Oct;62(5):511-9.
- Background: PubMed 2401588Troisi 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.
- Background: PubMed 2208753Landsberg L. Insulin resistance, energy balance and sympathetic nervous system activity. Clin Exp Hypertens A. 1990;12(5):817-30. doi: 10.3109/10641969009073502.
- Background: PubMed 2259240Landsberg L. The sympathoadrenal system, obesity and hypertension: an overview. J Neurosci Methods. 1990 Sep;34(1-3):179-86. doi: 10.1016/0165-0270(90)90056-l.
- Background: PubMed 1372851Sparrow 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. doi: 10.1378/chest.101.4.976.
- Background: PubMed 1288277Cassano 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. doi: 10.1093/oxfordjournals.aje.a116468.
- Background: PubMed 1288276Hu 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. doi: 10.1093/oxfordjournals.aje.a116467.
- Background: PubMed 1442652Troisi 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. doi: 10.1093/ajcn/56.6.1019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Hypertension, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005194, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.