The Role of Oxytocin-receptor Signalling in Physiological Regulation of Eating Behaviour in Individuals With Obesity

H-23059585

The present study evaluates appetite, glucose metabolism, gastrointestinal motility and energy expenditure in men and women with obesity (BMI 30-40 kg/m2) under oxytocin exposure compared to placebo.

2024-01-01

2024-12-31

2024-12-31

Recruiting

24

Inclusion Criteria: * Age 18-65 years * BMI between 30 and 40 kg/m2 (both included) * Percentage body fat (BF%) ≥25 for men and ≥32 for women (assessed by bioelectrical impedance analysis) * Informed oral and written consent Exclusion Criteria: * Anaemia (haemoglobin below normal range) * Alanine aminotransferase (ALT) \>2 times normal values * History of hepatobiliary and/or gastrointestinal disorder(s) * Kidney disease (serum creatinine above normal range and/or urine albumin-creatinine ratio (uACR) \>30 mg/g confirmed by two measures) * Previous gastric or intestinal resection, cholecystectomy and/or any major intra-abdominal surgery (including bariatric surgery) * Previous pancreatic disease and/or neoplasia * Regular tobacco smoking and/or use of other nicotine products * Glycated haemoglobin (HbA1c) ≥48 and/or type 1 diabetes or type 2 diabetes requiring medical treatment * Pituitary gland disorders * Initiation of special diets, lifestyle changes and/or weight loss \>5% of total body weight within three months prior to or during study period * Pregnancy or breastfeeding * Long QTc on electrocardiogram (ECG) at screening (≥0.45 seconds for men and ≥0.46 seconds for women) * Any physical or psychological condition or ongoing medication the investigator group suspect would interfere with trial participation

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 24, 'type': 'ESTIMATED'}}

2024-05-14