South Danish Obesity Initiative, Screening for Unrecognized Obesity Related Disease

Obesity Clinical Trial

— SDOI  

Official title:

South Danish Obesity Initiative (SDOI)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05176132
• Other study ID #: SDOI
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: September 1, 2030

Study information

• Verified date: October 2023
• Source: Hospital of South West Jutland
• Contact: Claus B Juhl, Prof. PhD MD
• Phone: 60867172
• Email: claus.bogh.juhl[@]rsyd.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2700
• Est. completion date: September 1, 2030
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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.
• Self management
Patients with no obesity related diseases will not be offered lifestyle intervention, but encouraged to physical activity (self management)
• No intervention
Control groups (BMI 20-25 and BMI 25-30)

Locations

Country	Name	City	State
Denmark	Hospital of South West Jutland, University hospital of Southern Denmark	Esbjerg

Sponsors (3)

Lead Sponsor	Collaborator
Claus Bogh Juhl	Odense University Hospital, Steno Diabetes Center Odense

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of unrecognized obesity-related diseases	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).	Baseline
Primary	Prevalence of unrecognized obesity-related diseases	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).	5 years
Secondary	Consultation systolic and diastolic blood pressure	Standard cut-of values	Baseline
Secondary	Consultation systolic and diastolic blood pressure	Standard cut-of values	1 year
Secondary	Consultation systolic and diastolic blood pressure	Standard cut-of values	5 years
Secondary	24 hour blood pressure	Measures mean blood pressure, day and night	Baseline
Secondary	24 hour blood pressure	Measures mean blood pressure, day and night	5 years
Secondary	HbA1c	HbA1c equal to or higher than 48 mmol/mol indicates diabetes	Baseline
Secondary	HbA1c	HbA1c equal to or higher than 48 mmol/mol indicates diabetes	1 year
Secondary	HbA1c	HbA1c equal to or higher than 48 mmol/mol indicates diabetes	5 years
Secondary	Prediabetes	Hba1c 43-47 indicates prediabetes	Baseline
Secondary	Prediabetes	Hba1c 43-47 indicates prediabetes	1 year
Secondary	Prediabetes	Hba1c 43-47 indicates prediabetes	5 years
Secondary	Low density lipoprotein	Dyslipidemia is defined as low density lipoprotein (LDL) > 3 mmol/l or high density lipoprotein (HDL) cholesterol < 1 mmol/l.	Baseline
Secondary	Low density lipoprotein	Dyslipidemia is defined as low density lipoprotein (LDL) > 3 mmol/l or high density lipoprotein (HDL) cholesterol < 1 mmol/l.	1 year
Secondary	Low density lipoprotein	Dyslipidemia is defined as low density lipoprotein (LDL) > 3 mmol/l or high density lipoprotein (HDL) cholesterol < 1 mmol/l.	5 years
Secondary	Berlin sleep apnea questionnaire	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.	Baseline
Secondary	Berlin sleep apnea questionnaire	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.	5 years
Secondary	Epworth Sleepiness Scale	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	Baseline
Secondary	Epworth Sleepiness Scale	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	5 years
Secondary	Apnea hypopnoea index (AHI)	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	Baseline
Secondary	Apnea hypopnoea index (AHI)	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	5 years
Secondary	Elastography	Quantifies liver-stiffness as a measure of non-alcoholic fatty liver disease, lower is better	Baseline
Secondary	Elastography	Quantifies liver-stiffness as a measure of non-alcoholic fatty liver disease, lower is better	5 years
Secondary	FEV1/FVC	Indication of Chronic obstructive pulmonary disease as measured by spirometry	Baseline
Secondary	FEV1/FVC	Indication of Chronic obstructive pulmonary disease as measured by spirometry	5 years
Secondary	EKG	Under resting conditions, standard 12 lead electrocardiography	Baseline
Secondary	EKG	Under resting conditions, standard 12 lead electrocardiography	5 years
Secondary	Ferriman-Gallwey score self-reported	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	Baseline
Secondary	Ferriman-Gallwey score self-reported	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	5 years
Secondary	Hand-grip force	Handgrip force: Higher is better, no defined cut-off value	Baseline
Secondary	Hand-grip force	Handgrip force: Higher is better, no defined cut-off value	1 year
Secondary	Hand-grip force	Handgrip force: Higher is better, no defined cut-off value	five years
Secondary	Fat-free mass	Fat-free mass as estimated by bioimpedance measure, higher is better, no cut-of value	Baseline
Secondary	Fat-free mass	Fat-free mass as estimated by bioimpedance measure, higher is better, no cut-of value	1 year
Secondary	Fat-free mass	Fat-free mass as estimated by bioimpedance measure, higher is better, no cut-of value	5 years
Secondary	Gait-speed	Gait Speed in 6 meters: High more than 1.1 m/s, Median 0.7-1.1 m/s, Low <0.7 m/s	Baseline
Secondary	Gait-speed	Gait Speed in 6 meters: High more than 1.1 m/s, Median 0.7-1.1 m/s, Low <0.7 m/s	1 year
Secondary	Gait-speed	Gait Speed in 6 meters: High more than 1.1 m/s, Median 0.7-1.1 m/s, Low <0.7 m/s	5 years
Secondary	Body weight	Participants are weighed in light clothes with no shoes or pocket items, lower is better	Baseline
Secondary	Body weight	Participants are weighed in light clothes with no shoes or pocket items, lower is better	1 year
Secondary	Body weight	Participants are weighed in light clothes with no shoes or pocket items, lower is better	5 years
Secondary	BMI	Body weight / m2, lower is better	Baseline
Secondary	BMI	Body weight / m2, lower is better	1 year
Secondary	BMI	Body weight / m2, lower is better	5 years
Secondary	Waist circumference	Lower is better	Baseline
Secondary	Waist circumference	Lower is better	1 year
Secondary	Waist circumference	Lower is better	5 years
Secondary	Work-ability Index	Measures the ability of a person to work, higher values are better, no cut-of value	Baseline
Secondary	Work-ability Index	Measures the ability of a person to work, higher values are better, no cut-of value	5 years
Secondary	Impact of weight on quality of life-lite	Measures weight associated quality of life, higher values are better, no cut-of value	Baseline
Secondary	Impact of weight on quality of life-lite	Measures weight associated quality of life, higher values are better, no cut-of value	1 year
Secondary	Impact of weight on quality of life-lite	Measures weight associated quality of life, higher values are better, no cut-of value	5 years
Secondary	Adult Eating Behavior Questionnaire	Measures eating behavior and appetite traits, descriptive	Baseline
Secondary	Adult Eating Behavior Questionnaire	Measures eating behavior and appetite traits, descriptive	1 year
Secondary	Adult Eating Behavior Questionnaire	Measures eating behavior and appetite traits, descriptive	5 years
Secondary	SDOI attitude to physical activity questionnaire	Measures a persons attitude to physical activity, higher is better, no cut-of value	baseline
Secondary	SDOI attitude to physical activity questionnaire	Measures a persons attitude to physical activity, higher is better, no cut-of value	1 year
Secondary	SDOI attitude to physical activity questionnaire	Measures a persons attitude to physical activity, higher is better, no cut-of value	5 years