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HAPPY: A Prospective Cohort Study of Aged People for Chronic Diseases

Sponsor
Seoul National University Bundang Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02640872
Collaborator
(none)
1,000
Enrollment
1
Location
68.5
Actual Duration (Months)
14.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a hospital-based, prospective cohort study to elucidate the predictive factors including muscle and fat mass for chronic diseases and mortality in elderly persons aged 60 years and older.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study is a hospital-based, prospective cohort study to elucidate the predictive factors among anthropometric and biochemical parameters and body composition information for chronic diseases including diabetes mellitus, myocardial infarction, stroke, osteoporosis, fracture, and cognitive dysfunction, and mortality in elderly persons aged 60 years and older.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Hospital-based Prospective Cohort Study With Aged People to Elucidate Predictive Factors Including Muscle and Fat Mass for Chronic Diseases and Mortality
    Actual Study Start Date :
    Jul 1, 2015
    Actual Primary Completion Date :
    Dec 31, 2018
    Actual Study Completion Date :
    Mar 15, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    HAPPY Cohort

    A elderly cohort for chronic diseases

    Outcome Measures

    Primary Outcome Measures

    1. Alll cause mortality [9 years]

    Secondary Outcome Measures

    1. Cardiometabolic mortality [9 years]

    2. Incidence of major adverse cardiac event including nonfatal myocardial infarction, nonfatal stroke, and unstable angina [9 years]

    3. Incidence of frailty defined by the Korean Fraility Index [9 years]

    4. Incidence of osteoporotic fracture [9 years]

    5. Incidence of cognitive dysfunction measured by minimental status examination [9 years]

    6. Development of sarcopenia defined by the Foundation for the National Institutes of Health (FNIH) criteria [9 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Aged 60 years and older

    • Capable of communication with the research team

    • Provided written informed consent

    Exclusion Criteria:

    • Age < 60 years

    • active malignancy

    • uncompensated liver cirrhosis

    • ESRD

    • severe cognitive impairment which cannot communicate with the research term

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Bundang Hospital Seongnam Gyeonggi Korea, Republic of 463-707

    Sponsors and Collaborators

    • Seoul National University Bundang Hospital

    Investigators

    • Principal Investigator: Soo Lim, MD, PhD, SNUBH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Soo Lim, MD, PhD, Seoul National University Bundang Hospital
    ClinicalTrials.gov Identifier:
    NCT02640872
    Other Study ID Numbers:
    • SNUBH-HAPPY Cohort
    First Posted:
    Dec 29, 2015
    Last Update Posted:
    Mar 30, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Soo Lim, MD, PhD, Seoul National University Bundang Hospital
    sarcopenia
    sarcopenic obesity
    osteoporosis
    fracture
    cardiovascular disease
    mortality
    Additional relevant MeSH terms:
    Sarcopenia
    Chronic Disease

    Study Results

    No Results Posted as of Mar 30, 2021