Status:
NOT_YET_RECRUITING
GLP-1 RA on Alcohol Consumption, Metabolism and Liver Parameters in Patients With Obesity and Fatty Liver Disease
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Adiposity
Fatty Liver
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
There is evidence that alcoholic beverage consumption significantly interacts with food energy intake. Furthermore, there is accumulating evidence showing independent, combined, and modifying effects ...
Detailed Description
In Switzerland, approximately 20% of the population is consuming more alcohol than recommended by the WHO. There is evidence that alcoholic beverage consumption significantly interacts with food energ...
Eligibility Criteria
Inclusion
- BMI ≥ 35 kg/m² OR BMI ≥ 28 kg/m² in the case of weight-related co-morbidities (pre-diabetes or type 2 diabetes mellitus, hypertension, dyslipidemia).
- Fatty liver disease (steatosis on ultrasound and/or CAP value on FS \> 238 dB/m)
- Age 18 - 80 years
- Alcohol Use Disorder Identification Test-C Score \>4 (AUDIT-C) Score ≥4 for women and ≥5 for men (as measured from AUDIT-questionnaire distributed in visit 1)
- Sufficient skills for German or French language (written and spoken)
- Signed informed consent
Exclusion
- Active illicit substance use
- AUDIT-score \< 5 (males)/ 4 (females) (as measured from AUDIT-questionnaire distributed in visit 1)
- Current treatment with drugs against alcohol dependence (disulfiram, acamprosate, naltrexone, baclofen and nalmefene)
- Any known contraindication to semaglutide
- Presence or history of a hepatic or extrahepatic malignancy from the previous 6 months
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06546384
Start Date
June 1 2025
End Date
April 30 2027
Last Update
March 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Bern
Bern, Switzerland, 3010