South Danish Obesity Initiative, Screening for Unrecognized Obesity Related Disease
ID: NCT05176132
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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.
Read Full Scientific Objectives & Methods
Obesity is associated with a variety of adverse health problems, and there is currently no effective scalable treatment with a durable effect. Additionally, well-known obesity related health problems are often underdiagnosed. A Danish cohort of people with BMI \>30 kg/m2 is established on University Hospital South West Jutland. Additionally, one control group with BMI 18.5-25 kg/m2 and one control group with BMI 25-30 kg/m2 will be included. Age range is defined as 18 and 60 years. To evaluate health status all participants are 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. Data will be collected from questionnaires (Impact of Weight related on Quality of Life, Attitude to physical activity questionnaire, Adult Eating Behavior questionnaire, Berlin sleep apnea and Epworths Sleepiness scale, PCOS related questionnaire including Ferriman-Gallwey score, Work Ability Index, and weight history); clinical laboratory variables (HbA1c, glucose, c-peptide, lipid status, thyroid stimulating hormone (TSH), triiodothyronine (T3), thyroxine (T4), hemoglobin, thrombocytes, alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), bilirubin, gamma glutamic transferase, lactate dehydrogenase (LDH), alkaline phosphatase, and creatinine levels); and anthropometric measurements (blood pressure, EKG, liver elastography, spirometry (forced expiratory volume during first second as a fraction of forced vital capacity (FEV1/FVC), hand grip strength, gait speed, and CT scan for estimation of the subcutaneous and visceral fat volume). People with diseases uncovered by the screening program will be referred to specialized departments or general practice for further assessment and treatment. A biobank (blood, feces, urine) is established for future research studies. Patients with obesity related diseases will be invited to participate in a personalized lifestyle intervention program with dietitians and physiotherapists focusing on health improvement through personal motivation, perceived limitations and body accept. Additionally, participants are invited to a 1 year follow-up. All participants, independent of disease status, will be invited for at new screening 5 years after the initial visit. The data collected for the cohort will be used to estimate the prevalence and development of new obesity-related diseases, and to identify predictors for obesity-related diseases. Finally, the effect of the lifestyle intervention-program will be evaluated.
Obese patients with obesity related diseases will be invited to participate in a personalized lifestyle intervention program with dieticians and physiotherapists focusing on health improvement through personal motivation and perceived limitations and body accept.
Patients with no obesity related diseases will not be offered lifestyle intervention, but encouraged to physical activity (self management)
Control groups (BMI 20-25 and BMI 25-30)
Treatment Arms Description
BMI above 30 kg/m2 and being 18 to 60 years of age. Since the initiative is open for the general obese population, the investigators did not define the size of the cohort, but expect around 500 referrals per year.
100 persons with normal weight (BMI 20 - 25 kg/m2) 18 to 60 years of age
100 persons with overweight (BMI 25 - 30 kg/m2) 18 to 60 years of age
- BMI \>30 (Obese cohort), BMI 20-25 (control group I), BMI 25-30 (control group II)
- Age 18-60 years
- None
Primary Outcome Measures
- Prevalence of unrecognized obesity-related diseases — Time Frame: Baseline
Undetected obesity-related diseases (hypertension, diabetes, dyslipidemia, sleep apnea, non-alcoholic fatty liver disease, chronic obstructive pulmonary disease, EKG-abnormalities, and polycystic ovary syndrome (PCOS).
- Prevalence of unrecognized obesity-related diseases — Time Frame: 5 years
Undetected obesity-related diseases (hypertension, diabetes, dyslipidemia, sleep apnea, non-alcoholic fatty liver disease, chronic obstructive pulmonary disease, EKG-abnormalities, and polycystic ovary syndrome (PCOS).
View Secondary Outcome Measures (57)
- Consultation systolic and diastolic blood pressure — Time Frame: Baseline
Standard cut-of values
- Consultation systolic and diastolic blood pressure — Time Frame: 1 year
Standard cut-of values
- Consultation systolic and diastolic blood pressure — Time Frame: 5 years
Standard cut-of values
- 24 hour blood pressure — Time Frame: Baseline
Measures mean blood pressure, day and night
- 24 hour blood pressure — Time Frame: 5 years
Measures mean blood pressure, day and night
- HbA1c — Time Frame: Baseline
HbA1c equal to or higher than 48 mmol/mol indicates diabetes
- HbA1c — Time Frame: 1 year
HbA1c equal to or higher than 48 mmol/mol indicates diabetes
- HbA1c — Time Frame: 5 years
HbA1c equal to or higher than 48 mmol/mol indicates diabetes
- Prediabetes — Time Frame: Baseline
Hba1c 43-47 indicates prediabetes
- Prediabetes — Time Frame: 1 year
Hba1c 43-47 indicates prediabetes
This trial is recruiting at 1 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 1 Facilities & Contact Sites
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- Juhl CB, Bladbjerg EM, Gram B, Knudsen T, Lauridsen MM, Nygaard NB, Drojdahl Ryg N, Skadhauge L, Munster AB. Prevalence of Obesity-Related Disease in a Danish Population - The Results of an Algorithm-Based Screening Program. Diabetes Metab Syndr Obes. 2024 Jun 19;17:2505-2517. doi: 10.2147/DMSO.S456028. eCollection 2024.PubMed ↗
View Official Medical/Scientific Title
South Danish Obesity Initiative (SDOI)