Clinical trial NCT05494138: Nutriomics and Artificial Intelligence Nutrition Obesity Cohort
Official title: Nutriomics and Artificial Intelligence Nutrition Obesity Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 650
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Differences of nutriomics according to obesity phenotypes
timeFrame: At five years of study
Secondary outcomes:
measure: Clinical events
timeFrame: three years, four years, five years, etc
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Division of Cardiology, Severance Hospital, Yonsei University College of Medicine
name: Sungha Park
role: PRINCIPAL_INVESTIGATOR
References: