ObesityNCT07542327
The Role of Autoantibodies Against G-protein Coupled Receptors in Obesity
An observational study of Obesity and Obesity & Overweight, run by Claus Bogh Juhl at 1 site in Denmark.
Trial summary
The purpose of this study is to explore if GPCR-autoantibodies: 1. are pressent in people living with obesity, and are associated with degree of obesity 2. if it is associated with obesity related diseases Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Obesity & Overweight, Obesity Type 2 Diabetes Mellitus
- How many people
- 160 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2026to 1 Sep 2027
- 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
- No healthy volunteers
- Adult
Study population: The South Danish Obesity Initiative (SDOI) cohort. This is an ongoing clinical initiative offering screening of a broad panel of obesity related diseases to individuals with BMI above 30 kg/m² and age between 18 and 60 years. People are referred from their general practitioners or from hospital departments and undergo screening for diabetes, dyslipidemia, obstructive sleep apnea, metabolic associated steatohepatitis and hypertension. In addition, a cohort of people with BMI 18.5 to 30 kg/m² has been assessed with an identical screening program with the purpose of serving as a control group. Only participants who gave informed consent to use their data for research purposes are included in this study.
Who may be able to join
- Inhabitant in the Region of Southern Denmark
- BMI above 30kg/m2
- age between 18 and 60 years.
Who cannot join
- individuals previously treated with GLP-1RA medication for any indication
- Individuals who have previously undergone bariatric surgery
- Individuals with type 1 diabetes
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
University Hospital of Southern Denmark, Esbjerg
Esbjerg, Region Syddanmark, 6700
Anitta Ø Johansen, Chief consultant, + 21338607 ext. +45, anitta.oehlenschlaeger@rsyd.dk
Claus B Juhl, Professor, MD, PhD
About this study
The purpose of this study is to explore if GPCR-autoantibodies:
- are pressent in people living with obesity, and are associated with degree of obesity
- if it is associated with obesity related diseases
Read the detailed description
The present study aims to investigate the role of GLP1-R autoantibodies in a large, deeply phenotyped obesity cohort. In an unblinded exploratory analysis, GLP1-R, GIP-R and ghrelin-R autoantibody levels will be measured using proprietary assay. The central hypothesis is that the presence and concentration of these autoantibodies is positively associated with the degree of obesity. Secondary we hypothesize that the presence and concentration of GLP1-R or GIP-R autoantibodies are associated with the presence of insulin resistance and prediabetes. As an exploratory approach we hypothesize that the presence and concentration of GLP1-R, GIP-R or ghrelin-R autoantibodies is associated with eating behavior as assessed by the validated questionnaire Adult Eating Behavior Questionnaire.
At present, it is unknown whether these autoantibodies exert an inhibitory, neutral, or agonistic effect on GLP1R, GIP-R or ghrelin-R signaling. Furthermore, it remains unclear whether individuals with obesity and diabetes-conditions associated with impaired GLP-1 signaling-exhibit a higher prevalence of GLP1R autoantibodies, or whether these autoantibodies differ functionally between diabetic and non-diabetic individuals. Addressing these questions may help explain interindividual variability in weight loss responses and uncover a novel immuno-endocrine mechanism relevant to obesity and metabolic disease.
The project will take advantage of the South Danish Obesity Initiative (SDOI) cohort. This is an ongoing clinical initiative offering screening of a broad panel of obesity related diseases to individuals with BMI above 30 kg/m² and age between 18 and 60 years. People are referred from their general practitioners or from hospital departments and undergo screening for diabetes, dyslipidemia, obstructive sleep apnea, metabolic-associated steatohepatitis and hypertension. In addition, the participants answer questionnaires including the Adult Eating Behavior Questionnaire. A Danish translation of this questionnaire has been validated, and the questionnaire allows evaluation of eating habits (Kolin M.E.I. et al, 2025. DOI:10.3390/nu17243824). A cohort of people with BMI 18.5 to 30 kg/m² has been assessed with an identical screening program with the purpose of serving as a control group. Only participants who gave informed consent to use their data for research purposes are included in this study. The SDOI screening protocol and initial results have previously been published (Juhl C.B. et al 2024. DOI:10.2147/DMSO.S456028).
In the present study we will include 160 participants from the SDOI cohort, of which 120 will be individuals living with obesity. Where 40 participants will have a BMI above 50 kg/m², 40 will have a BMI 40-50 kg/m², 40 will have a BMI 30-40 kg/m². The remaining 40 participants will be from the control cohort (BMI 18.5 to 25 kg/m²). The groups will be matched on sex and age (within 2 years). Individuals with type 1 diabetes and individuals treated with GLP-1RAs for any indication and individuals who have previously undergone bariatric surgery will not be included in the trial.
- Conditions
- Obesity, Obesity & Overweight, Obesity Type 2 Diabetes Mellitus, Obesity and Obesity-related Medical Conditions
- Keywords
- Obesity, obesity-related medical conditions, GPCR- autoantibodies
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The South Danish Obesity Initiative (SDOI) | The project will take advantage of the South Danish Obesity Initiative (SDOI) cohort. This is an ongoing clinical initiative, offering screening of a broad panel of obesity related diseases to individuals with BMI above 30 kg/m² and age between 18 and 60 years. People are referred from their general practitioners or from hospital departments and undergo screening for diabetes, dyslipidemia, obstructive sleep apnea, metabolic-associated steatohepatitis and hypertension. In addition, the participants answer questionnaires. A cohort of people with BMI 18.5 to 30 kg/m² has been assessed with an identical screening program with the purpose of serving as a control group. Only participants who gave informed consent to use their data for research purposes are included in this study. The study protocol and initial results have previously been published (Juhl C.B, et al 2024.DOI: 10.2147/DMSO.S456028). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exploring the pressence and role of GPCR-autoantibodies in obesity
explore the pressence of GPCR-autoantibodies in people living with obesity, and if there is any association with the degree of obesity
Measured: At the time of enrolement
Secondary outcomes (1)
Exploring the association between GPCR-autoantibodies and obesity related diseases
explore if the pressence of GPCR-autoantibodies is associated with obesity related diseases (pre-diabetes, type 2 diabetes and metabolic syndrome) in people living with obesity
Measured: At the time of enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cross-sectional
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Claus Bogh Juhl
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Claus Bogh Juhl, Esbjerg Hospital - University Hospital of Southern Denmark
- Investigators
- Claus B Juhl, Professor, MD, PhD, Principal investigator, University Hospital of Southern Denmark, Esbjerg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542327
- Sponsor's protocol ID
- 26/14976
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: GDPR regulations and patient anonymity
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Autoantibodies Against G-protein Coupled Receptors in Obesity
- ClinicalTrials.gov ID
- NCT07542327
- Acronym / sponsor ID
- 26/14976
- Conditions
- Obesity, Obesity & Overweight, Obesity Type 2 Diabetes Mellitus, Obesity and Obesity-related Medical Conditions
- Keywords
- Obesity, obesity-related medical conditions, GPCR- autoantibodies
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Claus Bogh JuhlUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 21 Apr 2026 (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.
The purpose of this study is to explore if GPCR-autoantibodies:
- are pressent in people living with obesity, and are associated with degree of obesity
- if it is associated with obesity related diseases
Detailed description
The present study aims to investigate the role of GLP1-R autoantibodies in a large, deeply phenotyped obesity cohort. In an unblinded exploratory analysis, GLP1-R, GIP-R and ghrelin-R autoantibody levels will be measured using proprietary assay. The central hypothesis is that the presence and concentration of these autoantibodies is positively associated with the degree of obesity. Secondary we hypothesize that the presence and concentration of GLP1-R or GIP-R autoantibodies are associated with the presence of insulin resistance and prediabetes. As an exploratory approach we hypothesize that the presence and concentration of GLP1-R, GIP-R or ghrelin-R autoantibodies is associated with eating behavior as assessed by the validated questionnaire Adult Eating Behavior Questionnaire.
At present, it is unknown whether these autoantibodies exert an inhibitory, neutral, or agonistic effect on GLP1R, GIP-R or ghrelin-R signaling. Furthermore, it remains unclear whether individuals with obesity and diabetes-conditions associated with impaired GLP-1 signaling-exhibit a higher prevalence of GLP1R autoantibodies, or whether these autoantibodies differ functionally between diabetic and non-diabetic individuals. Addressing these questions may help explain interindividual variability in weight loss responses and uncover a novel immuno-endocrine mechanism relevant to obesity and metabolic disease.
The project will take advantage of the South Danish Obesity Initiative (SDOI) cohort. This is an ongoing clinical initiative offering screening of a broad panel of obesity related diseases to individuals with BMI above 30 kg/m² and age between 18 and 60 years. People are referred from their general practitioners or from hospital departments and undergo screening for diabetes, dyslipidemia, obstructive sleep apnea, metabolic-associated steatohepatitis and hypertension. In addition, the participants answer questionnaires including the Adult Eating Behavior Questionnaire. A Danish translation of this questionnaire has been validated, and the questionnaire allows evaluation of eating habits (Kolin M.E.I. et al, 2025. DOI:10.3390/nu17243824). A cohort of people with BMI 18.5 to 30 kg/m² has been assessed with an identical screening program with the purpose of serving as a control group. Only participants who gave informed consent to use their data for research purposes are included in this study. The SDOI screening protocol and initial results have previously been published (Juhl C.B. et al 2024. DOI:10.2147/DMSO.S456028).
In the present study we will include 160 participants from the SDOI cohort, of which 120 will be individuals living with obesity. Where 40 participants will have a BMI above 50 kg/m², 40 will have a BMI 40-50 kg/m², 40 will have a BMI 30-40 kg/m². The remaining 40 participants will be from the control cohort (BMI 18.5 to 25 kg/m²). The groups will be matched on sex and age (within 2 years). Individuals with type 1 diabetes and individuals treated with GLP-1RAs for any indication and individuals who have previously undergone bariatric surgery will not be included in the trial.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The South Danish Obesity Initiative (SDOI) | – | –The project will take advantage of the South Danish Obesity Initiative (SDOI) cohort. This is an ongoing clinical initiative, offering screening of a broad panel of obesity related diseases to individuals with BMI above 30 kg/m² and age between 18 and 60 years. People are referred from their general practitioners or from hospital departments and undergo screening for diabetes, dyslipidemia, obstructive sleep apnea, metabolic-associated steatohepatitis and hypertension. In addition, the participants answer questionnaires. A cohort of people with BMI 18.5 to 30 kg/m² has been assessed with an identical screening program with the purpose of serving as a control group. Only participants who gave informed consent to use their data for research purposes are included in this study. The study protocol and initial results have previously been published (Juhl C.B, et al 2024.DOI: 10.2147/DMSO.S456028). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The South Danish Obesity Initiative (SDOI) cohort. This is an ongoing clinical initiative offering screening of a broad panel of obesity related diseases to individuals with BMI above 30 kg/m² and age between 18 and 60 years. People are referred from their general practitioners or from hospital departments and undergo screening for diabetes, dyslipidemia, obstructive sleep apnea, metabolic associated steatohepatitis and hypertension. In addition, a cohort of people with BMI 18.5 to 30 kg/m² has been assessed with an identical screening program with the purpose of serving as a control group. Only participants who gave informed consent to use their data for research purposes are included in this study.
Key inclusion criteria (3 listed)
- Inhabitant in the Region of Southern Denmark
- BMI above 30kg/m2
- age between 18 and 60 years.
Key exclusion criteria (3 listed)
- individuals previously treated with GLP-1RA medication for any indication
- Individuals who have previously undergone bariatric surgery
- Individuals with type 1 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Exploring the pressence and role of GPCR-autoantibodies in obesity
Time frame: At the time of enrolement
explore the pressence of GPCR-autoantibodies in people living with obesity, and if there is any association with the degree of obesity
1 secondary outcome
Exploring the association between GPCR-autoantibodies and obesity related diseases
Time frame: At the time of enrolment
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 24 Apr 2026.
- Individual participant dataSharing planned: Undecided. GDPR regulations and patient anonymity
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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, Professor, MD, PhD principal investigator
University Hospital of Southern Denmark, Esbjerg
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 and Obesity & Overweight, 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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 24 Apr 2026. 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 Tobias M Windedal, MD (42957945 ext. 45, tobias.midtvedt.windedal@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exploring the pressence and role of GPCR-autoantibodies in obesity (time frame: At the time of enrolement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2026.