Cardiovascular DiseasesNCT00094263
Long-Term Predictors of Morbidity in Older Age
An observational study of Cardiovascular Diseases and Diabetes Mellitus, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To use existing longitudinal data from the Chicago Heart Association and Western Electric Company studies to examine adiposity in relation to heart failure, multimorbidity and to examine heart rate in relation to incident diabetes. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Cardiovascular Diseases, Diabetes Mellitus, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 2004to Jul 2007
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To use existing longitudinal data from the Chicago Heart Association and Western Electric Company studies to examine adiposity in relation to heart failure, multimorbidity and to examine heart rate in relation to incident diabetes.
Read the detailed description
BACKGROUND:
Obesity is reaching epidemic proportions in the U.S. with over 50 percent of the adult population either overweight or obese. Obesity has been studied extensively as a risk factor for coronary heart disease and stroke, but has received less attention as a risk factor for congestive heart failure (CHF). Another area of limited investigation is the study of risk factors for multi morbidity, i.e. the occurrence of several morbid events at the same time, which is very common in older adults. Other areas of investigation in this study are possible associations between each of heart rate and dietary patterns with the development of diabetes. The Chicago Heart Association Detection Project and the Western Electric studies, both supported by the National Heart, Lung, and Blood Institute, are resources to study the above associations. Multiple measures of obesity are available at several different time points and follow-up data are available for 30-40 years which should increase the power of the study.
Data to be used for this project include baseline data collected in 1967-73 from 39,522 subjects from the Chicago Heart Association Study (CHA) and baseline and annual follow-up data from the Western Electric Study collected from 1957-1966 consisting of 2107 men, age 40-55 years in the Chicago area. Mortality follow-up for those 2 cohorts is accomplished via the National Death Index. Morbidity follow-up is accomplished by record linkage with Medicare files and to some extent by followup questionnaires for disease outcomes although the follow-up rate for the latter approach is only about 60 percent.
DESIGN NARRATIVE:
The study uses extensive existing data from the Chicago Heart Association (CHA) [20,854 men and 16,049 women aged 18-64 at baseline (1967-73)] and Western Electric (WE) [2,107 men aged 40- 55 at baseline (1957-58)] that include four comprehensive sources of outcomes: 1) mortality data from long-term follow-up; 2) morbidity and other data from Medicare claims for 19 years from 1984 to 2000; 3) multiple health questionnaires (CHA); and 4) repeated measures of adiposity from 8 annual re-examinations after baseline (WE). The study addresses the following specific aims: 1) to investigate in-depth the longitudinal associations of adiposity as assessed by several indices (body mass index, weight gain, subscapular and triceps skinfolds, and derived percent body fat) during young adulthood and middle age with mortality and morbidity from congestive heart failure later in life; 2) to delineate the relationships of adiposity assessed earlier in life with older-age multimorbidity, the coexistence of multiple pathological conditions of varying severity -- a very common but under-studied phenomenon among older adults; 3) to examine in-depth the associations of heart rate and changes in heart rate with incident diabetes, stratified by obesity status at baseline. As an exploratory aim, the study will assess whether a) higher fruit and vegetable and lower sugar intake; and b) higher dairy and calcium intake are associated with lower adiposity, smaller weight gain, and lower incidence of diabetes.
- Conditions
- Cardiovascular Diseases, Diabetes Mellitus, Heart Diseases, Heart Failure, Heart Failure, Congestive, Obesity
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Heart Diseases, Heart Failure, Obesity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2004 (estimated)
- Study startSep 2004
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Investigators
- Lijing Yan, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00094263
- Sponsor's protocol ID
- 1273
- Other IDs
- R21HL075259
- Status last verified
- Jan 2008
- First submitted
- 15 Oct 2004
- Last updated
- 18 Feb 2016
- Results posted
- No
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
- Long-Term Predictors of Morbidity in Older Age
- ClinicalTrials.gov ID
- NCT00094263
- Acronym / sponsor ID
- 1273
- Conditions
- Cardiovascular Diseases, Diabetes Mellitus, Heart Diseases, Heart Failure, Heart Failure, Congestive, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 2004
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 15 Oct 2004 (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 use existing longitudinal data from the Chicago Heart Association and Western Electric Company studies to examine adiposity in relation to heart failure, multimorbidity and to examine heart rate in relation to incident diabetes.
Detailed description
BACKGROUND:
Obesity is reaching epidemic proportions in the U.S. with over 50 percent of the adult population either overweight or obese. Obesity has been studied extensively as a risk factor for coronary heart disease and stroke, but has received less attention as a risk factor for congestive heart failure (CHF). Another area of limited investigation is the study of risk factors for multi morbidity, i.e. the occurrence of several morbid events at the same time, which is very common in older adults. Other areas of investigation in this study are possible associations between each of heart rate and dietary patterns with the development of diabetes. The Chicago Heart Association Detection Project and the Western Electric studies, both supported by the National Heart, Lung, and Blood Institute, are resources to study the above associations. Multiple measures of obesity are available at several different time points and follow-up data are available for 30-40 years which should increase the power of the study.
Data to be used for this project include baseline data collected in 1967-73 from 39,522 subjects from the Chicago Heart Association Study (CHA) and baseline and annual follow-up data from the Western Electric Study collected from 1957-1966 consisting of 2107 men, age 40-55 years in the Chicago area. Mortality follow-up for those 2 cohorts is accomplished via the National Death Index. Morbidity follow-up is accomplished by record linkage with Medicare files and to some extent by followup questionnaires for disease outcomes although the follow-up rate for the latter approach is only about 60 percent.
DESIGN NARRATIVE:
The study uses extensive existing data from the Chicago Heart Association (CHA) [20,854 men and 16,049 women aged 18-64 at baseline (1967-73)] and Western Electric (WE) [2,107 men aged 40- 55 at baseline (1957-58)] that include four comprehensive sources of outcomes: 1) mortality data from long-term follow-up; 2) morbidity and other data from Medicare claims for 19 years from 1984 to 2000; 3) multiple health questionnaires (CHA); and 4) repeated measures of adiposity from 8 annual re-examinations after baseline (WE). The study addresses the following specific aims: 1) to investigate in-depth the longitudinal associations of adiposity as assessed by several indices (body mass index, weight gain, subscapular and triceps skinfolds, and derived percent body fat) during young adulthood and middle age with mortality and morbidity from congestive heart failure later in life; 2) to delineate the relationships of adiposity assessed earlier in life with older-age multimorbidity, the coexistence of multiple pathological conditions of varying severity -- a very common but under-studied phenomenon among older adults; 3) to examine in-depth the associations of heart rate and changes in heart rate with incident diabetes, stratified by obesity status at baseline. As an exploratory aim, the study will assess whether a) higher fruit and vegetable and lower sugar intake; and b) higher dairy and calcium intake are associated with lower adiposity, smaller weight gain, and lower incidence of diabetes.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- 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.
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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.
Lijing Yan
Northwestern University
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Diabetes Mellitus, 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?
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.