Nutriomics and Artificial Intelligence Nutrition Obesity Cohort

NCT05494138 | Recruiting

• 1 other identifier: 4-2022-0645
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical events

  three years, four years, five years, etc

Study Arms (2)

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.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adults 19 years of age or older
• Obese patients with chronic diseases such as cardiovascular disease, hypertension, diabetes, and metabolic syndrome (BMI ≥ 25 kg/m2, \[BMI ≥ 30 kg/m2, including 10% or more\])
• Adults 19 years of age or older
• Those with BMI 18.5\~24.9 kg/m2

You may not qualify if:

• Serious non-cardiovascular disease with life expectancy less than 6 months
• Pregnant or suspected of being pregnant or are lactating
• Patients within 3 months of organ transplantation
• Patients currently being treated for acute transplant rejection
• Patients treated for acute coronary syndrome (myocardial infarction, unstable angina) and discharged within 6 months
• Patients with acute cerebral infarction within 6 months of being hospitalized and discharged
• Type 1 Diabetes
• Patients taking steroids, female hormones
• Those who have difficulty using smartphones
• Serious non-cardiovascular disease with life expectancy less than 6 months
• Pregnant or suspected of being pregnant or are lactating
• Persons who are continuously taking medications prescribed by a doctor due to chronic diseases excluding hypertension and dyslipidemia
• Within 5 years of diagnosis of malignant tumor
• Those who have difficulty using smartphones

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sungha Park

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sungha Park

CONTACT

+82-2-2228-8455; shpark0530@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2022
• First Posted: August 9, 2022
• Study Start: July 15, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2041
• Last Updated: August 9, 2022

Record last verified: 2022-08

Locations

KR (1)