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NCT06189001 Clinical Trial

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

Adiposity Clinical Trial

— FOxy  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06189001
Other study ID # H-23059585
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date December 31, 2024

Study information
Verified date May 2024
Source University Hospital, Gentofte, Copenhagen
Contact Ida Marie Gether, MD
Phone 004524246625
Email ida.marie.gether.01@regionh.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 24
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Oxytocin
Intravenous oxytocin 0.2 IU/min during experimental days
Other:
• Placebo (saline)
Intravenous saline during experimental days

Locations
Country Name City State
Denmark Center for Clinical Metabolisk Research Hellerup

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ad libitum food intake Amount consumed (kcal) Timepoint 190-220 minutes
Secondary Ad libitum food intake Amount consumed (kcal/kg) Timepoint 190-220 minutes
Secondary Sensations of hunger Visual analogue score (VAS) (0-100 mm) (bsAUC) Timepoint -100 to 160 minutes
Secondary Sensations of satiety Visual analogue score (VAS) (0-100 mm) (bsAUC) Timepoint -100 to 160 minutes
Secondary Sensations of fullness Visual analogue score (VAS) (0-100 mm) (bsAUC) Timepoint -100 to 160 minutes
Secondary Sensations of prospective food intake Visual analogue score (VAS) (0-100 mm) (bsAUC) Timepoint -100 to 160 minutes
Secondary Sensations of nausea Visual analogue score (VAS) (0-100 mm) (bsAUC) Timepoint -100 to 160 minutes
Secondary Sensations of thirst Visual analogue score (VAS) (0-100 mm) (bsAUC) Timepoint -100 to 160 minutes
Secondary Sensations of comfort Visual analogue score (VAS) (0-100 mm) (bsAUC) Timepoint -100 to 160 minutes
Secondary Composite appetite score Calculated from VAS of hunger, fullness and prospective food intake (bsAUC) Timepoint -100 to 160
Secondary Plasma concentrations of glucose Baseline Timepoint -95 to 180 minutes
Secondary Plasma concentrations of glucose bsAUC Timepoint -95 to 180 minutes
Secondary Plasma concentrations of glucose Peak value Timepoint -95 to 180 minutes
Secondary Serum concentrations of insulin Baseline Timepoint -95 to 180 minutes
Secondary Serum concentrations of insulin bsAUC Timepoint -95 to 180 minutes
Secondary Serum concentrations of C-peptide Baseline Timepoint -95 to 180 minutes
Secondary Serum concentrations of C-peptide bsAUC Timepoint -95 to 180 minutes
Secondary Beta cell function (C-peptide/glucose-ratio) Baseline Timepoint -95 to 180 minutes
Secondary Beta cell function (C-peptide/glucose-ratio) bsAUC Timepoint -95 to 180 minutes
Secondary Plasma concentrations of cholecystokinin Baseline Timepoint -95 to 180 minutes
Secondary Plasma concentrations of cholecystokinin bsAUC Timepoint -95 to 180 minutes
Secondary Energy expenditure (indirect calorimetry) Resting energy expenditure (REE) Timepoint -90 to 150 minutes
Secondary Energy expenditure (indirect calorimetry) Respiration exchange rate (RER) Timepoint -90 to 150 minutes
Secondary Snacking (ad libitum snack test) Amount consumed (kcal) Timepoint 225-235 minutes
Secondary Gallbladder volume (ml) Baseline Timepoint -120 to 180 minutes
Secondary Gallbladder volume (ml) AUC Timepoint -120 to 180 minutes
Secondary Gallbladder ejection fraction (%) GBEF% Timepoint -120 to 180 minutes
Secondary Gallbladder volume (ml) Nadir Timepoint -120 to 180 minutes
Secondary Gallbladder volume Time to nadir (min) Timepoint -120 to 180 minutes
Secondary Plasma concentrations of glucagon Baseline Timepoint -95 to 180 minutes
Secondary Plasma concentrations of glucagon bsAUC Timepoint -95 to 180 minutes
Secondary Plasma concentrations of GLP-1 Baseline Timepoint -95 to 180 minutes
Secondary Plasma concentrations of GLP-1 bsAUC Timepoint -95 to 180 minutes
Secondary Plasma concentrations of GIP Baseline Timepoint -95 to 180 minutes
Secondary Plasma concentrations of GIP bsAUC Timepoint -95 to 180 minutes
Secondary Plasma concentrations of peptide YY Baseline Timepoint -95 to 180 minutes
Secondary Plasma concentrations of peptide YY bsAUC Timepoint -95 to 180 minutes
Secondary Plasma concentrations of leptin Baseline Timepoint -95 to 180 minutes
Secondary Plasma concentrations of leptin bsAUC Timepoint -95 to 180 minutes
Secondary Plasma concentrations of ghrelin Baseline Timepoint -95 to 180 minutes
Secondary Plasma concentrations of ghrelin bsAUC Timepoint -95 to 180 minutes
Secondary Plasma concentrations of secretin Baseline Timepoint -95 to 180 minutes
Secondary Plasma concentrations of secretin bsAUC Timepoint -95 to 180 minutes
Secondary Gastric emptying (paracetamol absorption method) Baseline Timepoint -95 to 180 minutes
Secondary Gastric emptying (paracetamol absorption method) bsAUC Timepoint -95 to 180 minutes
Secondary Circulating levels of total amino acids Baseline Timepoint -95 to 180 minutes
Secondary Circulating levels of total amino acids bsAUC Timepoint -95 to 180 minutes
Secondary Lipid profile Baseline Timepoint -95 to 180 minutes
Secondary Lipid profile bsAUC Timepoint -95 to 180 minutes
Secondary Circulating levels of CTx Baseline Timepoint -95 to 180 minutes
Secondary Circulating levels of CTx bsAUC Timepoint -95 to 180 minutes
Secondary Circulating levels of P1NP Baseline Timepoint -95 to 180 minutes
Secondary Circulating levels of P1NP bsAUC Timepoint -95 to 180 minutes
Secondary Circulating levels of PTH Baseline Timepoint -95 to 180 minutes
Secondary Circulating levels of PTH bsAUC Timepoint -95 to 180 minutes
Secondary Circulating levels of calcium Baseline Timepoint -95 to 180 minutes
Secondary Circulating levels of calcium bsAUC Timepoint -95 to 180 minutes
Secondary Desire for specific foods VAS (0-100 mm). Baseline Timepoint -100 to 160 minutes
Secondary Desire for specific foods VAS (0-100 mm). bsAUC Timepoint -100 to 160 minutes
Secondary Duration of ad libitum meal Minutes Timepoint 190-220 minutes
Secondary Water intake during ad libitum meal ml Timepoint 190-220 minutes
Secondary Blood pressure Baseline Timepoint -75 to 185 minutes and timpoint 240 minutes
Secondary Blood pressure bsAUC Timepoint -75 to 185 minutes and timpoint 240 minutes
Secondary Heart rate Baseline Timepoint -75 to 185 minutes and timpoint 240 minutes
Secondary Heart rate bsAUC Timepoint -75 to 185 minutes and timpoint 240 minutes
Secondary Plasma concentrations of creatinine Baseline Timepoint -95 and 235 minutes
Secondary Plasma concentrations of creatinine End-infusion Timepoint -95 and 235 minutes
Secondary Plasma concentrations of potassium Baseline Timepoint -95 and 235 minutes
Secondary Plasma concentrations of potassium bsAUC Timepoint -95 and 235 minutes
Secondary Plasma concentrations of sodium Baseline Timepoint -95 and 235 minutes
Secondary Plasma concentrations of sodium End-infusion Timepoint -95 and 235 minutes
Secondary Happiness (Oxford Happiness Questionnaire (translated to Danish)) Points on scale from 29-174 Timepoint -65 and 160 minutes
Secondary Circulating levels of high-sensitive C-reactive protein (hsCRP) Baseline Timepoint -95 and 235 minutes
Secondary Circulating levels of C-reactive protein (hsCRP) End-infusion Timepoint -95 and 235 minutes
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