Clinical Trial

South Danish Obesity Initiative, Screening for Unrecognized Obesity Related Disease

Study acronym: SDOI
Recruiting
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Record status
This record was last updated October 19, 2023 (before its estimated September 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
People with BMI \>30 kg/m2 will be included in at population-based cohort. Additionally, one control group with BMI 18.5-25 kg/m2 and one control group with BMI 25-30 kg/m2 will be included. All participants with age 18 and 60 years. To evaluate health status participants will be screened by for undetected obesity-related diseases (hypertension, diabetes, dyslipidemia, sleep apnea, non-alcoholic fatty liver disease, chronic obstructive pulmonary disease, EKG-abnormalities, polycystic ovary syndrome (PCOS), and joint pain and for quality of life at baseline, 1 year, and 5 years. Additionally, anthropometric measurements are collected and a biobank is established for future research studies. People with obesity related disease will be offered participation in a 12 month personalized lifestyle intervention program aimed at improvement of health and self-perception. The collected data will be used to detect the prevalence for obesity-related disease to identify predictors for future obesity related disease and to evaluate the effect of a lifestyle intervention on health and quality of life.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2021-12-15; most recent amendment 2023-10-18.
Trial Details
NCT Number NCT05176132
Lead Sponsor Claus Bogh Juhl
Collaborators: Steno Diabetes Center Odense, Odense University Hospital
Conditions Obesity
Enrollment 2,700 participants
Start Date 2020-09-01
Primary Completion 2025-09-01 (estimated)
Study Completion 2030-09-01 (estimated)
Updated on ClinicalTrials.gov 2023-10-19