Overview

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

Status:
Recruiting
Trial end date:
2024-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University Hospital, Gentofte, Copenhagen
Treatments:
Oxytocin
Criteria
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