South Danish Obesity Initiative, Screening for Unrecognized Obesity Related Disease — SDOI  

Obesity Clinical Trial

Official title: South Danish Obesity Initiative (SDOI)

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Obesity

• NCT number: NCT05176132
• Study type: Observational [Patient Registry]
• Source: Hospital of South West Jutland
• Contact: Claus B Juhl, Prof. PhD MD
• Phone: 60867172
• Email: claus.bogh.juhl@rsyd.dk
• Status: Recruiting
• Start date: September 1, 2020
• Completion date: September 1, 2030