NCT06189001

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2023

Completed
27 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 3, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2024

Completed
Last Updated

March 27, 2025

Status Verified

May 1, 2024

Enrollment Period

8 months

First QC Date

December 5, 2023

Last Update Submit

March 24, 2025

Conditions

Adiposity

Keywords

oxytocinappetite regulationgastrointestinal motilityenergy expenditure

Outcome Measures

Primary Outcomes (1)

  • Ad libitum food intake

    Amount consumed (kcal)

    Timepoint 190-220 minutes

Secondary Outcomes (73)

  • Ad libitum food intake

    Timepoint 190-220 minutes

  • Sensations of hunger

    Timepoint -100 to 160 minutes

  • Sensations of satiety

    Timepoint -100 to 160 minutes

  • Sensations of fullness

    Timepoint -100 to 160 minutes

  • Sensations of prospective food intake

    Timepoint -100 to 160 minutes

  • +68 more secondary outcomes

Study Arms (2)

Oxytocin

EXPERIMENTAL

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

Drug: Oxytocin

Placebo

OTHER

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

Other: Placebo (saline)

Interventions

OxytocinDRUG

Intravenous oxytocin 0.2 IU/min during experimental days

Oxytocin
Placebo (saline)OTHER

Intravenous saline during experimental days

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Clinical Metabolisk Research

Hellerup, 2100, Denmark

Location

MeSH Terms

Conditions

Obesity

Interventions

OxytocinSodium Chloride

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD, PhD

Study Record Dates

First Submitted

December 5, 2023

First Posted

January 3, 2024

Study Start

January 1, 2024

Primary Completion

September 4, 2024

Study Completion

September 4, 2024

Last Updated

March 27, 2025

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)