ObesitySDOINCT05176132
South Danish Obesity Initiative, Screening for Unrecognized Obesity Related Disease
An observational study of Obesity, run by Claus Bogh Juhl at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Life style intervention (dietician+ physiotherapist) and Self management
- How many people
- 2,700 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2020to 1 Sep 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- BMI >30 (Obese cohort), BMI 20-25 (control group I), BMI 25-30 (control group II)
- Age 18-60 years
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Hospital of South West Jutland, University hospital of Southern Denmark
Esbjerg, 6700
Claus B Juhl, MD PhD, 60867172, claus.bogh.juhl@rsyd.dk
Nina Drøjdahl Ryg, MSc PhD, 26353163, nina.droejdahl.ryg@rsyd.dk
About this study
Official title: South Danish Obesity Initiative (SDOI)
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.
Read more
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 the 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.
- Conditions
- Obesity
- Being tested
- Life style intervention (dietician+ physiotherapist), Self management, No intervention
- Keywords
- Obesity, Lifestyle intervention, BMI, Cohort, sleep apnea, diabetes, PCOS, NAFLD, Hypertension, Hyperlipidemia
- Medical subject headings
- Obesity, Sleep Apnea Syndromes, Diabetes Mellitus, Non-alcoholic Fatty Liver Disease, Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 managementOther
Patients with no obesity related diseases will not be offered lifestyle intervention, but encouraged to physical activity (self management)
No interventionOther
Control groups (BMI 20-25 and BMI 25-30)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Life style intervention (dietician+ physiotherapist); Other: Self management | |
| CONTROL Normal weight (BMI 20-25) | 100 persons with normal weight (BMI 20 - 25 kg/m2) 18 to 60 years of age Receives: Other: No intervention | |
| CONTROL Overweight (BMI 25-30) | 100 persons with overweight (BMI 25 - 30 kg/m2) 18 to 60 years of age Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline
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).
Measured: 5 years
Secondary outcomes (57)
Consultation systolic and diastolic blood pressure
Standard cut-of values
Measured: Baseline
Consultation systolic and diastolic blood pressure
Standard cut-of values
Measured: 1 year
Consultation systolic and diastolic blood pressure
Standard cut-of values
Measured: 5 years
24 hour blood pressure
Measures mean blood pressure, day and night
Measured: Baseline
24 hour blood pressure
Measures mean blood pressure, day and night
Measured: 5 years
HbA1c
HbA1c equal to or higher than 48 mmol/mol indicates diabetes
Measured: Baseline
HbA1c
HbA1c equal to or higher than 48 mmol/mol indicates diabetes
Measured: 1 year
HbA1c
HbA1c equal to or higher than 48 mmol/mol indicates diabetes
Measured: 5 years
Prediabetes
Hba1c 43-47 indicates prediabetes
Measured: Baseline
Prediabetes
Hba1c 43-47 indicates prediabetes
Measured: 1 year
Prediabetes
Hba1c 43-47 indicates prediabetes
Measured: 5 years
Low density lipoprotein
Dyslipidemia is defined as low density lipoprotein (LDL) > 3 mmol/l or high density lipoprotein (HDL) cholesterol < 1 mmol/l.
Measured: Baseline
Low density lipoprotein
Dyslipidemia is defined as low density lipoprotein (LDL) > 3 mmol/l or high density lipoprotein (HDL) cholesterol < 1 mmol/l.
Measured: 1 year
Low density lipoprotein
Dyslipidemia is defined as low density lipoprotein (LDL) > 3 mmol/l or high density lipoprotein (HDL) cholesterol < 1 mmol/l.
Measured: 5 years
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.
Measured: Baseline
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.
Measured: 5 years
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
Measured: Baseline
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
Measured: 5 years
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
Measured: Baseline
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
Measured: 5 years
Elastography
Quantifies liver-stiffness as a measure of non-alcoholic fatty liver disease, lower is better
Measured: Baseline
Elastography
Quantifies liver-stiffness as a measure of non-alcoholic fatty liver disease, lower is better
Measured: 5 years
FEV1/FVC
Indication of Chronic obstructive pulmonary disease as measured by spirometry
Measured: Baseline
FEV1/FVC
Indication of Chronic obstructive pulmonary disease as measured by spirometry
Measured: 5 years
EKG
Under resting conditions, standard 12 lead electrocardiography
Measured: Baseline
EKG
Under resting conditions, standard 12 lead electrocardiography
Measured: 5 years
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
Measured: Baseline
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
Measured: 5 years
Hand-grip force
Handgrip force: Higher is better, no defined cut-off value
Measured: Baseline
Hand-grip force
Handgrip force: Higher is better, no defined cut-off value
Measured: 1 year
Hand-grip force
Handgrip force: Higher is better, no defined cut-off value
Measured: five years
Fat-free mass
Fat-free mass as estimated by bioimpedance measure, higher is better, no cut-of value
Measured: Baseline
Fat-free mass
Fat-free mass as estimated by bioimpedance measure, higher is better, no cut-of value
Measured: 1 year
Fat-free mass
Fat-free mass as estimated by bioimpedance measure, higher is better, no cut-of value
Measured: 5 years
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
Measured: Baseline
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
Measured: 1 year
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
Measured: 5 years
Body weight
Participants are weighed in light clothes with no shoes or pocket items, lower is better
Measured: Baseline
Body weight
Participants are weighed in light clothes with no shoes or pocket items, lower is better
Measured: 1 year
Body weight
Participants are weighed in light clothes with no shoes or pocket items, lower is better
Measured: 5 years
BMI
Body weight / m2, lower is better
Measured: Baseline
BMI
Body weight / m2, lower is better
Measured: 1 year
BMI
Body weight / m2, lower is better
Measured: 5 years
Waist circumference
Lower is better
Measured: Baseline
Waist circumference
Lower is better
Measured: 1 year
Waist circumference
Lower is better
Measured: 5 years
Work-ability Index
Measures the ability of a person to work, higher values are better, no cut-of value
Measured: Baseline
Work-ability Index
Measures the ability of a person to work, higher values are better, no cut-of value
Measured: 5 years
Impact of weight on quality of life-lite
Measures weight associated quality of life, higher values are better, no cut-of value
Measured: Baseline
Impact of weight on quality of life-lite
Measures weight associated quality of life, higher values are better, no cut-of value
Measured: 1 year
Impact of weight on quality of life-lite
Measures weight associated quality of life, higher values are better, no cut-of value
Measured: 5 years
Adult Eating Behavior Questionnaire
Measures eating behavior and appetite traits, descriptive
Measured: Baseline
Adult Eating Behavior Questionnaire
Measures eating behavior and appetite traits, descriptive
Measured: 1 year
Adult Eating Behavior Questionnaire
Measures eating behavior and appetite traits, descriptive
Measured: 5 years
SDOI attitude to physical activity questionnaire
Measures a persons attitude to physical activity, higher is better, no cut-of value
Measured: baseline
SDOI attitude to physical activity questionnaire
Measures a persons attitude to physical activity, higher is better, no cut-of value
Measured: 1 year
SDOI attitude to physical activity questionnaire
Measures a persons attitude to physical activity, higher is better, no cut-of value
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start1 Sep 2020
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,700 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Claus Bogh Juhl
- Sponsor type
- University, hospital or other
- Collaborators
- Steno Diabetes Center Odense, Odense University Hospital
- Responsible party
- Sponsor-investigator, Claus Bogh Juhl, Esbjerg Hospital - University Hospital of Southern Denmark
- Investigators
- Claus B Juhl, Prof. PhD MD, Principal investigator, Hospital South West Jutland, University hospital of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176132
- Sponsor's protocol ID
- SDOI
- Acronym
- SDOI
- Status last verified
- Oct 2023
- First submitted
- 10 Nov 2021
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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 38910914
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- South Danish Obesity Initiative (SDOI)
- ClinicalTrials.gov ID
- NCT05176132
- Acronym / sponsor ID
- SDOI / SDOI
- Conditions
- Obesity
- Keywords
- Obesity, Lifestyle intervention, BMI, Cohort, sleep apnea, diabetes, PCOS, NAFLD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,700 participants (estimated)
- Lead sponsor
- Claus Bogh JuhlUniversity, hospital or other
- Collaborators
- Steno Diabetes Center Odense, Odense University Hospital
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OBESE (BMI>30) | – | Other: Life style intervention (dietician+ physiotherapist), Other: Self managementBMI 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. |
| CONTROL Normal weight (BMI 20-25) | – | Other: No intervention100 persons with normal weight (BMI 20 - 25 kg/m2) 18 to 60 years of age |
| CONTROL Overweight (BMI 25-30) | – | Other: No intervention100 persons with overweight (BMI 25 - 30 kg/m2) 18 to 60 years of age |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- BMI >30 (Obese cohort), BMI 20-25 (control group I), BMI 25-30 (control group II)
- Age 18-60 years
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | OBESE (BMI>30) |
| Self managementPatients with no obesity related diseases will not be offered lifestyle intervention, but encouraged to physical activity (self management) | Other | OBESE (BMI>30) |
| No interventionControl groups (BMI 20-25 and BMI 25-30) | Other | CONTROL Normal weight (BMI 20-25), CONTROL Overweight (BMI 25-30) |
Primary outcome
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).
57 secondary outcomes
Consultation systolic and diastolic blood pressure
Time frame: Baseline
Consultation systolic and diastolic blood pressure
Time frame: 1 year
Consultation systolic and diastolic blood pressure
Time frame: 5 years
24 hour blood pressure
Time frame: Baseline
24 hour blood pressure
Time frame: 5 years
HbA1c
Time frame: Baseline
HbA1c
Time frame: 1 year
HbA1c
Time frame: 5 years
Prediabetes
Time frame: Baseline
Prediabetes
Time frame: 1 year
Prediabetes
Time frame: 5 years
Low density lipoprotein
Time frame: Baseline
Low density lipoprotein
Time frame: 1 year
Low density lipoprotein
Time frame: 5 years
Berlin sleep apnea questionnaire
Time frame: Baseline
Berlin sleep apnea questionnaire
Time frame: 5 years
Epworth Sleepiness Scale
Time frame: Baseline
Epworth Sleepiness Scale
Time frame: 5 years
Apnea hypopnoea index (AHI)
Time frame: Baseline
Apnea hypopnoea index (AHI)
Time frame: 5 years
Elastography
Time frame: Baseline
Elastography
Time frame: 5 years
FEV1/FVC
Time frame: Baseline
FEV1/FVC
Time frame: 5 years
EKG
Time frame: Baseline
EKG
Time frame: 5 years
Ferriman-Gallwey score self-reported
Time frame: Baseline
Ferriman-Gallwey score self-reported
Time frame: 5 years
Hand-grip force
Time frame: Baseline
Hand-grip force
Time frame: 1 year
Hand-grip force
Time frame: five years
Fat-free mass
Time frame: Baseline
Fat-free mass
Time frame: 1 year
Fat-free mass
Time frame: 5 years
Gait-speed
Time frame: Baseline
Gait-speed
Time frame: 1 year
Gait-speed
Time frame: 5 years
Body weight
Time frame: Baseline
Body weight
Time frame: 1 year
Body weight
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Derived from this study: PubMed 38910914Juhl 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claus B Juhl, Prof. PhD MD principal investigator
Hospital South West Jutland, University hospital of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Claus Bogh Juhl at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claus B Juhl, Prof. PhD MD (60867172, claus.bogh.juhl@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of unrecognized obesity-related diseases (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05176132, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023; AzTrials last refreshed its copy on 26 Oct 2026.