Nutriomics and Artificial Intelligence Nutrition Obesity Cohort

NCT ID: NCT05494138

Last Updated: 2022-08-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 650 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-15
• Study Completion Date: 2041-08-31

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.

Detailed Description

The obese group will enroll 500 people within 1 year of study initiation and follow-up annually. The control group will enroll 30 patients a year for 5 years.

Conditions

Obesity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

The obese group

Obese patients (BMI ≥25 kg/m2) with chronic diseases such as cardiovascular disease, hypertension, diabetes, and metabolic syndrome. More than 10% of the patients in the obese group will be patients with a BMI ≥30.

No interventions assigned to this group

The control group

Adults with BMI 18.5\~24.9 kg/m2.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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])

1. Adults 19 years of age or older

2. Those with BMI 18.5~24.9 kg/m2

Exclusion Criteria

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

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sungha Park

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology, Severance Hospital, Yonsei University College of Medicine

Locations

Yonsei University Health System, Severance Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Sungha Park

Role: CONTACT

shpark0530@yuhs.ac

+82-2-2228-8455

Facility Contacts

Sungha Park

Role: primary

shpark0530@yuhs.ac

+82-2-2228-8455

Other Identifiers

4-2022-0645

Identifier Type: -

Identifier Source: org_study_id