CompletedNot Applicable

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

Denmark25 participantsStarted 2024-01-01

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ad libitum food intake

Timeframe: Timepoint 190-220 minutes

Trial details

NCT IDNCT06189001

SponsorUniversity Hospital, Gentofte, Copenhagen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-04

View on ClinicalTrials.gov More Adiposity trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.