South Danish Obesity Initiative, Screening for Unrecognized Obesity Related Disease (SDOI)

• ClinicalTrials.gov Identifier: NCT05176132
• Recruitment Status: Recruiting
• First Posted: January 4, 2022
• Last Update Posted: October 19, 2023
• Sponsor: Claus Bogh Juhl
• Collaborators: Steno Diabetes Center Odense; Odense University Hospital
• Information provided by (Responsible Party): Claus Bogh Juhl, Hospital of South West Jutland

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Obesity	Other: Life style intervention (dietician+ physiotherapist); Other: Self management; Other: No intervention

Detailed 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.

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 2700 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 5 Years
• Official Title: South Danish Obesity Initiative (SDOI)
• Actual Study Start Date: September 1, 2020
• Estimated Primary Completion Date: September 1, 2025
• Estimated Study Completion Date: September 1, 2030

Groups and Cohorts

Group/Cohort	Intervention/treatment
OBESE (BMI>30); 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.	Other: Life style intervention (dietician+ physiotherapist); 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.; Other: Self management; Patients with no obesity related diseases will not be offered lifestyle intervention, but encouraged to physical activity (self management)
CONTROL Normal weight (BMI 20-25); 100 persons with normal weight (BMI 20 - 25 kg/m2) 18 to 60 years of age	Other: No intervention; Control groups (BMI 20-25 and BMI 25-30)
CONTROL Overweight (BMI 25-30); 100 persons with overweight (BMI 25 - 30 kg/m2) 18 to 60 years of age	Other: No intervention; Control groups (BMI 20-25 and BMI 25-30)

Outcome Measures

Primary Outcome Measures :

1. 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).
2. 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).

Secondary Outcome Measures :

1. Consultation systolic and diastolic blood pressure [ Time Frame: Baseline ]
   Standard cut-of values
2. Consultation systolic and diastolic blood pressure [ Time Frame: 1 year ]
   Standard cut-of values
3. Consultation systolic and diastolic blood pressure [ Time Frame: 5 years ]
   Standard cut-of values
4. 24 hour blood pressure [ Time Frame: Baseline ]
   Measures mean blood pressure, day and night
5. 24 hour blood pressure [ Time Frame: 5 years ]
   Measures mean blood pressure, day and night
6. HbA1c [ Time Frame: Baseline ]
   HbA1c equal to or higher than 48 mmol/mol indicates diabetes
7. HbA1c [ Time Frame: 1 year ]
   HbA1c equal to or higher than 48 mmol/mol indicates diabetes
8. HbA1c [ Time Frame: 5 years ]
   HbA1c equal to or higher than 48 mmol/mol indicates diabetes
9. Prediabetes [ Time Frame: Baseline ]
   Hba1c 43-47 indicates prediabetes
10. Prediabetes [ Time Frame: 1 year ]
    Hba1c 43-47 indicates prediabetes
11. Prediabetes [ Time Frame: 5 years ]
    Hba1c 43-47 indicates prediabetes
12. Low density lipoprotein [ Time Frame: Baseline ]
    Dyslipidemia is defined as low density lipoprotein (LDL) > 3 mmol/l or high density lipoprotein (HDL) cholesterol < 1 mmol/l.
13. Low density lipoprotein [ Time Frame: 1 year ]
    Dyslipidemia is defined as low density lipoprotein (LDL) > 3 mmol/l or high density lipoprotein (HDL) cholesterol < 1 mmol/l.
14. Low density lipoprotein [ Time Frame: 5 years ]
    Dyslipidemia is defined as low density lipoprotein (LDL) > 3 mmol/l or high density lipoprotein (HDL) cholesterol < 1 mmol/l.
15. Berlin sleep apnea questionnaire [ Time Frame: Baseline ]
    Berlin sleep apnea questionnaire: The Berlin Questionnaire consists of three categories designed to elicit information regarding snoring (category 1), daytime somnolence (category 2), and the presence of obesity and/or hypertension (category 3). Categories 1 and 2 are considered positive if 2 or more responses are positive category 3 is considered positive if 1 response is positive and/or the body mass index is greater than 30 kg per meter squared. A patient is considered to have a high likelihood of sleep disordered breathing if 2 or more categories are positive.
16. Berlin sleep apnea questionnaire [ Time Frame: 5 years ]
    Berlin sleep apnea questionnaire: The Berlin Questionnaire consists of three categories designed to elicit information regarding snoring (category 1), daytime somnolence (category 2), and the presence of obesity and/or hypertension (category 3). Categories 1 and 2 are considered positive if 2 or more responses are positive category 3 is considered positive if 1 response is positive and/or the body mass index is greater than 30 kg per meter squared. A patient is considered to have a high likelihood of sleep disordered breathing if 2 or more categories are positive.
17. Epworth Sleepiness Scale [ Time Frame: Baseline ]
    Epworth Sleepiness Scale: Score 0-24. 0-5 Lower Normal Daytime Sleepiness, 6-10 Higher Normal Daytime Sleepiness, 11-12 Mild Excessive Daytime Sleepiness 13-15 Moderate Excessive Daytime Sleepiness, 16-24 Severe Excessive Daytime Sleepiness
18. Epworth Sleepiness Scale [ Time Frame: 5 years ]
    Epworth Sleepiness Scale: Score 0-24. 0-5 Lower Normal Daytime Sleepiness, 6-10 Higher Normal Daytime Sleepiness, 11-12 Mild Excessive Daytime Sleepiness 13-15 Moderate Excessive Daytime Sleepiness, 16-24 Severe Excessive Daytime Sleepiness
19. Apnea hypopnoea index (AHI) [ Time Frame: Baseline ]
    Quantifies sleep apnea cardiorespiratory monitoring: AHI < 5 per hour=normal or minimal, AHI ≥ 5, but < 15 per hour: mild, AHI ≥ 15, but < 30 per hour moderate and AHI ≥ 30 per hour: severe
20. Apnea hypopnoea index (AHI) [ Time Frame: 5 years ]
    Quantifies sleep apnea cardiorespiratory monitoring: AHI < 5 per hour=normal or minimal, AHI ≥ 5, but < 15 per hour: mild, AHI ≥ 15, but < 30 per hour moderate and AHI ≥ 30 per hour: severe
21. Elastography [ Time Frame: Baseline ]
    Quantifies liver-stiffness as a measure of non-alcoholic fatty liver disease, lower is better
22. Elastography [ Time Frame: 5 years ]
    Quantifies liver-stiffness as a measure of non-alcoholic fatty liver disease, lower is better
23. FEV1/FVC [ Time Frame: Baseline ]
    Indication of Chronic obstructive pulmonary disease as measured by spirometry
24. FEV1/FVC [ Time Frame: 5 years ]
    Indication of Chronic obstructive pulmonary disease as measured by spirometry
25. EKG [ Time Frame: Baseline ]
    Under resting conditions, standard 12 lead electrocardiography
26. EKG [ Time Frame: 5 years ]
    Under resting conditions, standard 12 lead electrocardiography
27. Ferriman-Gallwey score self-reported [ Time Frame: Baseline ]
    Measures hirsutism and indicates risk of Polycystic ovary syndrome (PCOS): Whole body equal or less than 10: normal, over 10: increased, Face: more than 2 is considered high and indicates hirsutism
28. Ferriman-Gallwey score self-reported [ Time Frame: 5 years ]
    Measures hirsutism and indicates risk of Polycystic ovary syndrome (PCOS): Whole body equal or less than 10: normal, over 10: increased, Face: more than 2 is considered high and indicates hirsutism
29. Hand-grip force [ Time Frame: Baseline ]
    Handgrip force: Higher is better, no defined cut-off value
30. Hand-grip force [ Time Frame: 1 year ]
    Handgrip force: Higher is better, no defined cut-off value
31. Hand-grip force [ Time Frame: five years ]
    Handgrip force: Higher is better, no defined cut-off value
32. Fat-free mass [ Time Frame: Baseline ]
    Fat-free mass as estimated by bioimpedance measure, higher is better, no cut-of value
33. Fat-free mass [ Time Frame: 1 year ]
    Fat-free mass as estimated by bioimpedance measure, higher is better, no cut-of value
34. Fat-free mass [ Time Frame: 5 years ]
    Fat-free mass as estimated by bioimpedance measure, higher is better, no cut-of value
35. Gait-speed [ Time Frame: Baseline ]
    Gait Speed in 6 meters: High more than 1.1 m/s, Median 0.7-1.1 m/s, Low <0.7 m/s
36. Gait-speed [ Time Frame: 1 year ]
    Gait Speed in 6 meters: High more than 1.1 m/s, Median 0.7-1.1 m/s, Low <0.7 m/s
37. Gait-speed [ Time Frame: 5 years ]
    Gait Speed in 6 meters: High more than 1.1 m/s, Median 0.7-1.1 m/s, Low <0.7 m/s
38. Body weight [ Time Frame: Baseline ]
    Participants are weighed in light clothes with no shoes or pocket items, lower is better
39. Body weight [ Time Frame: 1 year ]
    Participants are weighed in light clothes with no shoes or pocket items, lower is better
40. Body weight [ Time Frame: 5 years ]
    Participants are weighed in light clothes with no shoes or pocket items, lower is better
41. BMI [ Time Frame: Baseline ]
    Body weight / m2, lower is better
42. BMI [ Time Frame: 1 year ]
    Body weight / m2, lower is better
43. BMI [ Time Frame: 5 years ]
    Body weight / m2, lower is better
44. Waist circumference [ Time Frame: Baseline ]
    Lower is better
45. Waist circumference [ Time Frame: 1 year ]
    Lower is better
46. Waist circumference [ Time Frame: 5 years ]
    Lower is better
47. Work-ability Index [ Time Frame: Baseline ]
    Measures the ability of a person to work, higher values are better, no cut-of value
48. Work-ability Index [ Time Frame: 5 years ]
    Measures the ability of a person to work, higher values are better, no cut-of value
49. Impact of weight on quality of life-lite [ Time Frame: Baseline ]
    Measures weight associated quality of life, higher values are better, no cut-of value
50. Impact of weight on quality of life-lite [ Time Frame: 1 year ]
    Measures weight associated quality of life, higher values are better, no cut-of value
51. Impact of weight on quality of life-lite [ Time Frame: 5 years ]
    Measures weight associated quality of life, higher values are better, no cut-of value
52. Adult Eating Behavior Questionnaire [ Time Frame: Baseline ]
    Measures eating behavior and appetite traits, descriptive
53. Adult Eating Behavior Questionnaire [ Time Frame: 1 year ]
    Measures eating behavior and appetite traits, descriptive
54. Adult Eating Behavior Questionnaire [ Time Frame: 5 years ]
    Measures eating behavior and appetite traits, descriptive
55. SDOI attitude to physical activity questionnaire [ Time Frame: baseline ]
    Measures a persons attitude to physical activity, higher is better, no cut-of value
56. SDOI attitude to physical activity questionnaire [ Time Frame: 1 year ]
    Measures a persons attitude to physical activity, higher is better, no cut-of value
57. SDOI attitude to physical activity questionnaire [ Time Frame: 5 years ]
    Measures a persons attitude to physical activity, higher is better, no cut-of value

Biospecimen Retention:   Samples With DNA

Blood sample Feces sample Urine sample

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

Participants with BMI > 30 refered from 1) Genaral practice, 2) Other hospital Departments at Hosital South West Jutland, or 3) Psychiatric Department.

The uptake area are 5 muncipalities with mixed urban and rural areas.

Criteria

Inclusion Criteria:

• BMI >30 (Obese cohort), BMI 20-25 (control group I), BMI 25-30 (control group II)
• Age 18-60 years

Exclusion Criteria:

• None

Contacts and Locations

Contacts

Contact: Claus B Juhl, Prof. PhD MD; 60867172; claus.bogh.juhl@rsyd.dk

Contact: Nina Drøjdahl Ryg, MSc PhD; 26353163; nina.droejdahl.ryg@rsyd.dk

Locations

Denmark

Hospital of South West Jutland, University hospital of Southern Denmark; Recruiting

Esbjerg, Denmark, 6700

Contact: Claus B Juhl, MD PhD 60867172 claus.bogh.juhl@rsyd.dk

Contact: Nina Drøjdahl Ryg, MSc PhD 26353163 nina.droejdahl.ryg@rsyd.dk

Sponsors and Collaborators

Claus Bogh Juhl

Steno Diabetes Center Odense

Odense University Hospital

Investigators

• Principal Investigator: Claus B Juhl, Prof. PhD MD; Hospital South West Jutland, University hospital of Southern Denmark

More Information

• Responsible Party: Claus Bogh Juhl, Professor, MD, PhD, Hospital of South West Jutland
• ClinicalTrials.gov Identifier: NCT05176132
• Other Study ID Numbers: SDOI
• First Posted: January 4, 2022
• Last Update Posted: October 19, 2023
• Last Verified: October 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Claus Bogh Juhl, Hospital of South West Jutland:

Obesity; Lifestyle intervention; BMI; Cohort; sleep apnea; diabetes; PCOS; NAFLD; Hypertension; Hyperlipidemia

Additional relevant MeSH terms:

Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight