Status:
RECRUITING
Behavioral Therapy and GLP-1 Analogue Effects on Binge Eating, Weight, and Coping in Obesity
Lead Sponsor:
Haukeland University Hospital
Collaborating Sponsors:
University of Bergen
Conditions:
Binge Eating Disorder Associated With Obesity
Binge Eating Disorder
Eligibility:
All Genders
18-65 years
Brief Summary
This study is a clinical, longitudinal, non-randomized, prospective observational study that seeks to compare the treatment effects and safety of using GLP-1 analogues versus not using appetite suppre...
Eligibility Criteria
Inclusion criteria
- Severe obesity defined as BMI >40 kg/m2 or 35 kg/m2 with obesity-related comorbidities: coronary artery disease, heart failure, hypertension, atrial fibrillation, cerebral stroke, venous thromboembolism, obstructive sleep apnea, obesity hypoventilation syndrome, type 2 diabetes mellitus, non-alcoholic fatty liver disease, dyslipidemia, osteoarthritis and polecystic ovary syndrome
- Age between 18 to 65 years
- Diagnosis of BED according to DSM-5 criteria
- Willingness to participate and provide informed consent
- Able to understand and communicate in Norwegian
Exclusion criteria
- Pregnant or lactating women, as well as women planning pregnancy within one year.
- Current use medications with major effects on appetite regulation or weight (including, but not limited to systemic glucocorticoids and antipsychotic medication)
- Renal failure with estimated glomerular filtration rate less than 30 mL/min/1,73m2
- Liver failure with either ASAT and/or ALAT 5 times upper reference limit, or ALP and/or GT more than 3 times upper reference limit, or clinical signs of liver decompensation
- Active cancer
- Previous medullary thyroid cancer
- Previous pancreatitis
- Active substance abuse (but previous drug abuse accepted)
- Medical or psychological treatment within the specialized health care service for eating disorders within the last 6 months.
- Ongoing severe psychiatric disease that makes them unable to follow the lifestyle treatment program
- Any illness or prior treatment that in the opinion of the investigator would jeopardize the patient's participation in the study or impact integrity and/or quality of study data.
- Previous bariatric surgery
- Use of appetite suppressing drugs (e.g., GLP-1 analogues and/or naltrexone/bupropion) within the last 6 months
- Participation in another clinical study involving an investigational medicinal product within 1 month prior to study inclusion
Key Trial Info
Start Date :
July 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07042672
Start Date
July 1 2025
End Date
December 31 2028
Last Update
September 15 2025
Active Locations (1)
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1
Haukeland University Hospital
Bergen, Vestland, Norway, 5021