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

NCT ID: NCT06189001

Last Updated: 2025-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-09-04

Brief Summary

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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

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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.

Conditions

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Adiposity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Oxytocin

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

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

Intravenous oxytocin 0.2 IU/min during experimental days

Placebo

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

Group Type OTHER

Placebo (saline)

Intervention Type OTHER

Intravenous saline during experimental days

Interventions

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Oxytocin

Intravenous oxytocin 0.2 IU/min during experimental days

Intervention Type DRUG

Placebo (saline)

Intravenous saline during experimental days

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Filip Krag Knop

Professor, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Center for Clinical Metabolisk Research

Hellerup, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-23059585

Identifier Type: -

Identifier Source: org_study_id

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