NCT02640872

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 29, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

3.5 years

First QC Date

December 19, 2015

Last Update Submit

March 29, 2021

Conditions

AgingSarcopenia

Keywords

sarcopeniasarcopenic obesityosteoporosisfracturecardiovascular diseasemortality

Outcome Measures

Primary Outcomes (1)

  • Alll cause mortality

    9 years

Secondary Outcomes (6)

  • Cardiometabolic mortality

    9 years

  • Incidence of major adverse cardiac event including nonfatal myocardial infarction, nonfatal stroke, and unstable angina

    9 years

  • Incidence of frailty defined by the Korean Fraility Index

    9 years

  • Incidence of osteoporotic fracture

    9 years

  • Incidence of cognitive dysfunction measured by minimental status examination

    9 years

  • +1 more secondary outcomes

Study Arms (1)

HAPPY Cohort

A elderly cohort for chronic diseases

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Aged 60 years and older Capable of communication with the research team Provided written informed consent

You may qualify if:

  • Aged 60 years and older
  • Capable of communication with the research team
  • Provided written informed consent

You may not qualify if:

  • Age \< 60 years
  • active malignancy
  • uncompensated liver cirrhosis
  • ESRD
  • severe cognitive impairment which cannot communicate with the research term

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

for measuring biomarkers

MeSH Terms

Conditions

SarcopeniaOsteoporosisFractures, BoneCardiovascular Diseases

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesWounds and Injuries

Study Officials

  • Soo Lim, MD, PhD

    SNUBH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

December 19, 2015

First Posted

December 29, 2015

Study Start

July 1, 2015

Primary Completion

December 31, 2018

Study Completion

March 15, 2021

Last Updated

March 30, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)