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NCT Number: NCT05176132

South Danish Obesity Initiative, Screening for Unrecognized Obesity Related Disease

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.

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Key information

Conditions

Obesity Apnea Body Weight Cardiovascular Diseases Diabetes Mellitus Digestive System Diseases Dyslipidemias Dyssomnias Endocrine System Diseases Fatty Liver Glucose Metabolism Disorders Hyperlipidemias Hypertension Lipid Metabolism Disorders Liver Diseases Metabolic Diseases Nervous System Diseases Non-alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital of South West Jutland, University hospital of Southern Denmark

Esbjerg, 6700, Denmark

Location status: Recruiting

Location contact

Claus B Juhl, MD PhD

CONTACT

[email protected]

60867172

Nina Drøjdahl Ryg, MSc PhD

CONTACT

[email protected]

26353163

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Life style intervention (dietician+ physiotherapist)

Other

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.

Self management

Other

Patients with no obesity related diseases will not be offered lifestyle intervention, but encouraged to physical activity (self management)

No intervention

Other

Control groups (BMI 20-25 and BMI 25-30)

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Claus B Juhl, Prof. PhD MD

CONTACT

[email protected]

60867172

Nina Drøjdahl Ryg, MSc PhD

CONTACT

[email protected]

26353163

Sponsors and collaborators

Lead sponsor

Claus Bogh Juhl

Other

Collaborators

  • Odense University Hospital
  • Steno Diabetes Center Odense

Registry information

Official study title

South Danish Obesity Initiative (SDOI)

Acronym: SDOI

Important dates

Study start
2020
Primary completion
2025
Study completion
2030
First posted
Jan 4, 2022
Registry last updated
Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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