NCT05494138 Nutriomics and Artificial Intelligence Nutrition Obesity Cohort
| NCT ID | NCT05494138 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yonsei University |
| Condition | Obesity |
| Study Type | OBSERVATIONAL |
| Enrollment | 650 participants |
| Start Date | 2022-07-15 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 650 participants in total. It began in 2022-07-15 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to establish a prospective cohort. From registration to the 5th year, basic investigation, specific examinations for cardiovascular and metabolic disease, basic blood tests, collection of human material samples, and clinical event follow-up are conducted yearly. The obese group will be examined yearly, and telephone follow-up will be conducted if necessary. The control group will participate in the baseline survey once enrollment and clinical event follow-up by phone will be conducted annually thereafter. From the 6th year, only clinical event follow-up will be conducted.
Eligibility Criteria
Inclusion criteria for the obese group 1. Adults 19 years of age or older 2. Obese patients with chronic diseases such as cardiovascular disease, hypertension, diabetes, and metabolic syndrome (BMI ≥ 25 kg/m2, \[BMI ≥ 30 kg/m2, including 10% or more\]) Inclusion criteria for the control group 1. Adults 19 years of age or older 2. Those with BMI 18.5\~24.9 kg/m2 Exclusion criteria for the obese group 1. Serious non-cardiovascular disease with life expectancy less than 6 months 2. Pregnant or suspected of being pregnant or are lactating 3. Patients within 3 months of organ transplantation 4. Patients currently being treated for acute transplant rejection 5. Patients treated for acute coronary syndrome (myocardial infarction, unstable angina) and discharged within 6 months 6. Patients with acute cerebral infarction within 6 months of being hospitalized and discharged 7. Type 1 Diabetes 8. Patients taking steroids, female hormones 9. Those who have difficulty using smartphones Exclusion criteria for the control group 1. Serious non-cardiovascular disease with life expectancy less than 6 months 2. Pregnant or suspected of being pregnant or are lactating 3. Persons who are continuously taking medications prescribed by a doctor due to chronic diseases excluding hypertension and dyslipidemia 4. Within 5 years of diagnosis of malignant tumor 5. Those who have difficulty using smartphones
Contact & Investigator
Sungha Park
PRINCIPAL INVESTIGATOR
Division of Cardiology, Severance Hospital, Yonsei University College of Medicine
Frequently Asked Questions
Who can join the NCT05494138 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05494138 currently recruiting?
Yes, NCT05494138 is actively recruiting participants. Contact the research team at shpark0530@yuhs.ac for enrollment information.
Where is the NCT05494138 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05494138 clinical trial?
NCT05494138 is sponsored by Yonsei University. The principal investigator is Sungha Park at Division of Cardiology, Severance Hospital, Yonsei University College of Medicine. The trial plans to enroll 650 participants.
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