Nutriomics and Artificial Intelligence Nutrition Obesity Cohort

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity

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.

• Study Type: Observational
• Enrollment (Anticipated): 650

Contacts and Locations

• Study Contact: Name: Sungha Park; Phone Number: +82-2-2228-8455; Email: shpark0530@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Yonsei University Health system, Severance Hospital
    • Contact: Sungha Park; Phone Number: +82-2-2228-8455; Email: shpark0530@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The obese group will be selected from patients who visit the department of cardiology or endocrinology for the management of chronic diseases. The control group will be selected from among those who voluntarily participate in the epidemiological study of normal participants.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.
The control group; Adults with BMI 18.5~24.9 kg/m2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences of nutriomics according to obesity phenotypes	Cross-sectional analysis of nutriomics of normal control group and obese patients	At five years of study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical events	A composite of all-cause mortality, cardiovascular mortality, non-fatal myocardial infarction, non-fatal stroke, revascularization of coronary artery, and heart failure hospitalization	three years, four years, five years, etc

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Sungha Park, Division of Cardiology, Severance Hospital, Yonsei University College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Anticipated): August 31, 2026
• Study Completion (Anticipated): August 31, 2041

Study Registration Dates

• First Submitted: August 7, 2022
• First Submitted That Met QC Criteria: August 7, 2022
• First Posted (Actual): August 9, 2022

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 7, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 4-2022-0645

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: When there is a request for data sharing from other researchers, the principal investigator will review it and decide whether to share it or not.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No