Aging Clinical Trial
— HAPPYOfficial title:
A Hospital-based Prospective Cohort Study With Aged People to Elucidate Predictive Factors Including Muscle and Fat Mass for Chronic Diseases and Mortality
| NCT number | NCT02640872 |
| Other study ID # | SNUBH-HAPPY Cohort |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 2015 |
| Est. completion date | March 15, 2021 |
| Verified date | March 2021 |
| Source | Seoul National University Bundang Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1000 |
| Est. completion date | March 15, 2021 |
| Est. primary completion date | December 31, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 60 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Seoul National University Bundang Hospital | Seongnam | Gyeonggi |
| Lead Sponsor | Collaborator |
|---|---|
| Seoul National University Bundang Hospital |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Alll cause mortality | 9 years | ||
| Secondary | Cardiometabolic mortality | 9 years | ||
| Secondary | Incidence of major adverse cardiac event including nonfatal myocardial infarction, nonfatal stroke, and unstable angina | 9 years | ||
| Secondary | Incidence of frailty defined by the Korean Fraility Index | 9 years | ||
| Secondary | Incidence of osteoporotic fracture | 9 years | ||
| Secondary | Incidence of cognitive dysfunction measured by minimental status examination | 9 years | ||
| Secondary | Development of sarcopenia defined by the Foundation for the National Institutes of Health (FNIH) criteria | 9 years |
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