Long-Term Predictors of Morbidity in Older Age
Primary Purpose
Cardiovascular Diseases, Diabetes Mellitus, Heart Diseases
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00094263
First Posted
October 15, 2004
Last Updated
February 17, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00094263
Brief Title
Long-Term Predictors of Morbidity in Older Age
Study Type
Observational
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Diabetes Mellitus, Heart Diseases, Heart Failure, Heart Failure, Congestive, Obesity
7. Study Design
10. Eligibility
Sex
All
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lijing Yan
Organizational Affiliation
Northwestern University
12. IPD Sharing Statement
Learn more about this trial
Long-Term Predictors of Morbidity in Older Age
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