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Recruiting NCT05494138

Nutriomics and Artificial Intelligence Nutrition Obesity Cohort

Observational Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Obesity. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Differences of nutriomics according to obesity phenotypes [Time frame: At five years of study]
Secondary outcome measures (1)
  • Clinical events [Time frame: three years, four years, five years, etc]

Eligibility criteria

Inclusion criteria for the obese group

  • 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, \[BMI ≥ 30 kg/m2, including 10% or more\])

Inclusion criteria for the control group

  • Adults 19 years of age or older
  • Those with BMI 18.5\~24.9 kg/m2

Exclusion criteria for the obese group

  • 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

Exclusion criteria for the control group

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • Yonsei University Health System, Severance Hospital — Seoul

Identifiers

NCT: NCT05494138 · 4-2022-0645

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗