AgingHAPPYNCT02640872
A Prospective Cohort Study of Aged People for Chronic Diseases
An observational study of Aging and Sarcopenia, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Sarcopenia
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2015to 15 Mar 2021
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Aged 60 years and older Capable of communication with the research team Provided written informed consent
Who may be able to join
- Aged 60 years and older
- Capable of communication with the research team
- Provided written informed consent
Who cannot join
- Age < 60 years
- active malignancy
- uncompensated liver cirrhosis
- ESRD
- severe cognitive impairment which cannot communicate with the research term
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
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
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.
Read the 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.
- Conditions
- Aging, Sarcopenia
- Keywords
- sarcopenia, sarcopenic obesity, osteoporosis, fracture, cardiovascular disease, mortality
- Medical subject headings
- Sarcopenia, Osteoporosis, Fractures, Bone, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HAPPY Cohort | A elderly cohort for chronic diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alll cause mortality
Measured: 9 years
Secondary outcomes (6)
Cardiometabolic mortality
Measured: 9 years
Incidence of major adverse cardiac event including nonfatal myocardial infarction, nonfatal stroke, and unstable angina
Measured: 9 years
Incidence of frailty defined by the Korean Fraility Index
Measured: 9 years
Incidence of osteoporotic fracture
Measured: 9 years
Incidence of cognitive dysfunction measured by minimental status examination
Measured: 9 years
Development of sarcopenia defined by the Foundation for the National Institutes of Health (FNIH) criteria
Measured: 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startJul 2015
- Primary completion31 Dec 2018
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo Lim, Seoul National University Bundang Hospital
- Investigators
- Soo Lim, MD, PhD, Principal investigator, SNUBH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640872
- Sponsor's protocol ID
- SNUBH-HAPPY Cohort
- Acronym
- HAPPY
- Status last verified
- Mar 2021
- First submitted
- 19 Dec 2015
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02640872
- Acronym / sponsor ID
- HAPPY / SNUBH-HAPPY Cohort
- Conditions
- Aging, Sarcopenia
- Keywords
- sarcopenia, sarcopenic obesity, osteoporosis, fracture, cardiovascular disease, mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 29 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HAPPY Cohort | – | –A elderly cohort for chronic diseases |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Aged 60 years and older Capable of communication with the research team Provided written informed consent
Key inclusion criteria (3 listed)
- Aged 60 years and older
- Capable of communication with the research team
- Provided written informed consent
Key exclusion criteria (5 listed)
- Age < 60 years
- active malignancy
- uncompensated liver cirrhosis
- ESRD
- severe cognitive impairment which cannot communicate with the research term
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Alll cause mortality
Time frame: 9 years
6 secondary outcomes
Cardiometabolic mortality
Time frame: 9 years
Incidence of major adverse cardiac event including nonfatal myocardial infarction, nonfatal stroke, and unstable angina
Time frame: 9 years
Incidence of frailty defined by the Korean Fraility Index
Time frame: 9 years
Incidence of osteoporotic fracture
Time frame: 9 years
Incidence of cognitive dysfunction measured by minimental status examination
Time frame: 9 years
Development of sarcopenia defined by the Foundation for the National Institutes of Health (FNIH) criteria
Time frame: 9 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soo Lim, MD, PhD principal investigator
SNUBH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Sarcopenia, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. 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 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does the primary outcome measure?
Alll cause mortality (time frame: 9 years). It is what the study was designed to measure, not a finding.
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 30 Mar 2021.