NCT07542327

Brief Summary

The purpose of this study is to explore if GPCR-autoantibodies:

  1. 1.are pressent in people living with obesity, and are associated with degree of obesity
  2. 2.if it is associated with obesity related diseases

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
12mo left

Started Sep 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 14, 2026

Last Update Submit

April 21, 2026

Conditions

Keywords

Obesityobesity-related medical conditionsGPCR- autoantibodies

Outcome Measures

Primary Outcomes (1)

  • 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

    At the time of enrolement

Secondary Outcomes (1)

  • Exploring the association between GPCR-autoantibodies and obesity related diseases

    At the time of enrolment

Study Arms (1)

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).

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Inhabitant in the Region of Southern Denmark
  • BMI above 30kg/m2
  • age between 18 and 60 years.

You may not qualify if:

  • individuals previously treated with GLP-1RA medication for any indication
  • Individuals who have previously undergone bariatric surgery
  • Individuals with type 1 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Southern Denmark, Esbjerg

Esbjerg, Region Syddanmark, 6700, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood and blood serum samples

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Claus B Juhl, Professor, MD, PhD

    University Hospital of Southern Denmark, Esbjerg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tobias M Windedal, MD

CONTACT

Claus B Juhl, Professor, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, MD, PhD.

Study Record Dates

First Submitted

April 14, 2026

First Posted

April 21, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations