Nutriomics and Artificial Intelligence Nutrition Obesity Cohort

Obesity Clinical Trial

Official title:

Nutriomics and Artificial Intelligence Nutrition Obesity Cohort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05494138
• Other study ID #: 4-2022-0645
• Status: Recruiting
• Start date: July 15, 2022
• Est. completion date: August 31, 2041

Study information

• Verified date: August 2022
• Source: Yonsei University
• Contact: Sungha Park
• Phone: +82-2-2228-8455
• Email: shpark0530[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: August 31, 2041
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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