Status:
COMPLETED
The Role of Oxytocin-receptor Signalling in Physiological Regulation of Eating Behaviour in Individuals with Obesity
Lead Sponsor:
University Hospital, Gentofte, Copenhagen
Conditions:
Adiposity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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.
Detailed Description
In a randomised, double-blind, placebo-controlled, crossover fashion, 24 participants will complete two experimental days (A and B) including a mixed meal test and an ad libitum meal test. The procedu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 4 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06189001
Start Date
January 1 2024
End Date
September 4 2024
Last Update
March 27 2025
Active Locations (1)
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1
Center for Clinical Metabolisk Research
Hellerup, Denmark, 2100