Clinical trial NCT06189001: The Role of Oxytocin-receptor Signalling in Physiological Regulation of Eating Behaviour in Individuals with Obesity
Official title: The Role of Oxytocin-receptor Signalling in Physiological Regulation of Eating Behaviour in Individuals with Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adiposity
Keywords: oxytocin
appetite regulation
gastrointestinal motility
energy expenditure
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Ad libitum food intake
timeFrame: Timepoint 190-220 minutes
Secondary outcomes:
measure: Ad libitum food intake
timeFrame: Timepoint 190-220 minutes
measure: Sensations of hunger
timeFrame: Timepoint -100 to 160 minutes
measure: Sensations of satiety
timeFrame: Timepoint -100 to 160 minutes
measure: Sensations of fullness
timeFrame: Timepoint -100 to 160 minutes
measure: Sensations of prospective food intake
timeFrame: Timepoint -100 to 160 minutes
measure: Sensations of nausea
timeFrame: Timepoint -100 to 160 minutes
measure: Sensations of thirst
timeFrame: Timepoint -100 to 160 minutes
measure: Sensations of comfort
timeFrame: Timepoint -100 to 160 minutes
measure: Composite appetite score
timeFrame: Timepoint -100 to 160
measure: Plasma concentrations of glucose
timeFrame: Timepoint -95 to 180 minutes
measure: Plasma concentrations of glucose
timeFrame: Timepoint -95 to 180 minutes
measure: Plasma concentrations of glucose
timeFrame: Timepoint -95 to 180 minutes
measure: Serum concentrations of insulin
timeFrame: Timepoint -95 to 180 minutes
measure: Serum concentrations of insulin
timeFrame: Timepoint -95 to 180 minutes
measure: Serum concentrations of C-peptide
timeFrame: Timepoint -95 to 180 minutes
measure: Serum concentrations of C-peptide
timeFrame: Timepoint -95 to 180 minutes
measure: Beta cell function (C-peptide/glucose-ratio)
timeFrame: Timepoint -95 to 180 minutes
measure: Beta cell function (C-peptide/glucose-ratio)
timeFrame: Timepoint -95 to 180 minutes
measure: Plasma concentrations of cholecystokinin
timeFrame: Timepoint -95 to 180 minutes
measure: Plasma concentrations of cholecystokinin
timeFrame: Timepoint -95 to 180 minutes
measure: Energy expenditure (indirect calorimetry)
timeFrame: Timepoint -90 to 150 minutes
measure: Energy expenditure (indirect calorimetry)
timeFrame: Timepoint -90 to 150 minutes
measure: Snacking (ad libitum snack test)
timeFrame: Timepoint 225-235 minutes
measure: Gallbladder volume (ml)
timeFrame: Timepoint -120 to 180 minutes
measure: Gallbladder volume (ml)
timeFrame: Timepoint -120 to 180 minutes
measure: Gallbladder ejection fraction (%)
timeFrame: Timepoint -120 to 180 minutes
measure: Gallbladder volume (ml)
timeFrame: Timepoint -120 to 180 minutes
measure: Gallbladder volume
timeFrame: Timepoint -120 to 180 minutes
measure: Plasma concentrations of glucagon
timeFrame: Timepoint -95 to 180 minutes
measure: Plasma concentrations of glucagon
timeFrame: Timepoint -95 to 180 minutes
measure: Plasma concentrations of GLP-1
timeFrame: Timepoint -95 to 180 minutes
measure: Plasma concentrations of GLP-1
timeFrame: Timepoint -95 to 180 minutes
measure: Plasma concentrations of GIP
timeFrame: Timepoint -95 to 180 minutes
measure: Plasma concentrations of GIP
timeFrame: Timepoint -95 to 180 minutes
measure: Plasma concentrations of peptide YY
timeFrame: Timepoint -95 to 180 minutes
measure: Plasma concentrations of peptide YY
timeFrame: Timepoint -95 to 180 minutes
measure: Plasma concentrations of leptin
timeFrame: Timepoint -95 to 180 minutes
measure: Plasma concentrations of leptin
timeFrame: Timepoint -95 to 180 minutes
measure: Plasma concentrations of ghrelin
timeFrame: Timepoint -95 to 180 minutes
measure: Plasma concentrations of ghrelin
timeFrame: Timepoint -95 to 180 minutes
measure: Plasma concentrations of secretin
timeFrame: Timepoint -95 to 180 minutes
measure: Plasma concentrations of secretin
timeFrame: Timepoint -95 to 180 minutes
measure: Gastric emptying (paracetamol absorption method)
timeFrame: Timepoint -95 to 180 minutes
measure: Gastric emptying (paracetamol absorption method)
timeFrame: Timepoint -95 to 180 minutes
measure: Circulating levels of total amino acids
timeFrame: Timepoint -95 to 180 minutes
measure: Circulating levels of total amino acids
timeFrame: Timepoint -95 to 180 minutes
measure: Lipid profile
timeFrame: Timepoint -95 to 180 minutes
measure: Lipid profile
timeFrame: Timepoint -95 to 180 minutes
measure: Circulating levels of CTx
timeFrame: Timepoint -95 to 180 minutes
measure: Circulating levels of CTx
timeFrame: Timepoint -95 to 180 minutes
measure: Circulating levels of P1NP
timeFrame: Timepoint -95 to 180 minutes
measure: Circulating levels of P1NP
timeFrame: Timepoint -95 to 180 minutes
measure: Circulating levels of PTH
timeFrame: Timepoint -95 to 180 minutes
measure: Circulating levels of PTH
timeFrame: Timepoint -95 to 180 minutes
measure: Circulating levels of calcium
timeFrame: Timepoint -95 to 180 minutes
measure: Circulating levels of calcium
timeFrame: Timepoint -95 to 180 minutes
measure: Desire for specific foods
timeFrame: Timepoint -100 to 160 minutes
measure: Desire for specific foods
timeFrame: Timepoint -100 to 160 minutes
measure: Duration of ad libitum meal
timeFrame: Timepoint 190-220 minutes
measure: Water intake during ad libitum meal
timeFrame: Timepoint 190-220 minutes
measure: Blood pressure
timeFrame: Timepoint -75 to 185 minutes and timpoint 240 minutes
measure: Blood pressure
timeFrame: Timepoint -75 to 185 minutes and timpoint 240 minutes
measure: Heart rate
timeFrame: Timepoint -75 to 185 minutes and timpoint 240 minutes
measure: Heart rate
timeFrame: Timepoint -75 to 185 minutes and timpoint 240 minutes
measure: Plasma concentrations of creatinine
timeFrame: Timepoint -95 and 235 minutes
measure: Plasma concentrations of creatinine
timeFrame: Timepoint -95 and 235 minutes
measure: Plasma concentrations of potassium
timeFrame: Timepoint -95 and 235 minutes
measure: Plasma concentrations of potassium
timeFrame: Timepoint -95 and 235 minutes
measure: Plasma concentrations of sodium
timeFrame: Timepoint -95 and 235 minutes
measure: Plasma concentrations of sodium
timeFrame: Timepoint -95 and 235 minutes
measure: Happiness (Oxford Happiness Questionnaire (translated to Danish))
timeFrame: Timepoint -65 and 160 minutes
measure: Circulating levels of high-sensitive C-reactive protein (hsCRP)
timeFrame: Timepoint -95 and 235 minutes
measure: Circulating levels of C-reactive protein (hsCRP)
timeFrame: Timepoint -95 and 235 minutes
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Center for Clinical Metabolisk Research
Study officials:
References: