AzTrials
AzTrials

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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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.

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.

  1. First posted15 Oct 2004 (estimated)
  2. Study startSep 2004
  3. Primary completionJul 2007
  4. Study completionJul 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in