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

University Hospital, Gentofte, Copenhagen

Status: Completed

Conditions: Adiposity

Treatments: Other: Placebo (saline); Drug: Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT06189001

H-23059585

Details and patient eligibility

About

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.

Full 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 procedures during the two experimental days are similar except for intravenous infusion of oxytocin on experimental day A and placebo (saline) on experimental day B, respectively. On experimental days, oxytocin or placebo infusion will be started at timepoint -60 minutes. At timepoint 0 minutes, participants will ingest a liquid mixed meal. After 190 minutes, participants are served an ad libitum meal followed by ad libitum snacks.

Enrollment: 25 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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25 participants in 2 patient groups

Oxytocin

Experimental group

Description:

Intravenous oxytocin 0.2 IU/minute for 300 minutes Approx. 500 ml

Treatment:

Drug: Oxytocin

Placebo

Other group

Description:

intravenous saline (0.9% NaCl) infusion for 300 minutes Approx. 500 ml

Treatment:

Other: Placebo (saline)