The Role of Oxytocin-receptor Signalling in Physiological Regulation of Eating Behaviour in Individuals With Obesity
- Registration Number
- NCT06189001
- Lead Sponsor
- University Hospital, Gentofte, Copenhagen
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Oxytocin Oxytocin Intravenous oxytocin 0.2 IU/minute for 300 minutes Approx. 500 ml Placebo Placebo (saline) intravenous saline (0.9% NaCl) infusion for 300 minutes Approx. 500 ml
- Primary Outcome Measures
Name Time Method Ad libitum food intake Timepoint 190-220 minutes Amount consumed (kcal)
- Secondary Outcome Measures
Name Time Method Heart rate Timepoint -75 to 185 minutes and timpoint 240 minutes bsAUC
Plasma concentrations of sodium Timepoint -95 and 235 minutes End-infusion
Sensations of hunger Timepoint -100 to 160 minutes Visual analogue score (VAS) (0-100 mm) (bsAUC)
Gastric emptying (paracetamol absorption method) Timepoint -95 to 180 minutes bsAUC
Water intake during ad libitum meal Timepoint 190-220 minutes ml
Blood pressure Timepoint -75 to 185 minutes and timpoint 240 minutes bsAUC
Plasma concentrations of creatinine Timepoint -95 and 235 minutes End-infusion
Plasma concentrations of potassium Timepoint -95 and 235 minutes bsAUC
Circulating levels of high-sensitive C-reactive protein (hsCRP) Timepoint -95 and 235 minutes Baseline
Circulating levels of C-reactive protein (hsCRP) Timepoint -95 and 235 minutes End-infusion
Sensations of prospective food intake Timepoint -100 to 160 minutes Visual analogue score (VAS) (0-100 mm) (bsAUC)
Sensations of nausea Timepoint -100 to 160 minutes Visual analogue score (VAS) (0-100 mm) (bsAUC)
Sensations of thirst Timepoint -100 to 160 minutes Visual analogue score (VAS) (0-100 mm) (bsAUC)
Sensations of comfort Timepoint -100 to 160 minutes Visual analogue score (VAS) (0-100 mm) (bsAUC)
Composite appetite score Timepoint -100 to 160 Calculated from VAS of hunger, fullness and prospective food intake (bsAUC)
Serum concentrations of insulin Timepoint -95 to 180 minutes bsAUC
Serum concentrations of C-peptide Timepoint -95 to 180 minutes bsAUC
Beta cell function (C-peptide/glucose-ratio) Timepoint -95 to 180 minutes bsAUC
Ad libitum food intake Timepoint 190-220 minutes Amount consumed (kcal/kg)
Gallbladder volume (ml) Timepoint -120 to 180 minutes Nadir
Gallbladder ejection fraction (%) Timepoint -120 to 180 minutes GBEF%
Circulating levels of total amino acids Timepoint -95 to 180 minutes bsAUC
Lipid profile Timepoint -95 to 180 minutes bsAUC
Sensations of satiety Timepoint -100 to 160 minutes Visual analogue score (VAS) (0-100 mm) (bsAUC)
Sensations of fullness Timepoint -100 to 160 minutes Visual analogue score (VAS) (0-100 mm) (bsAUC)
Plasma concentrations of glucose Timepoint -95 to 180 minutes Peak value
Plasma concentrations of cholecystokinin Timepoint -95 to 180 minutes bsAUC
Energy expenditure (indirect calorimetry) Timepoint -90 to 150 minutes Respiration exchange rate (RER)
Snacking (ad libitum snack test) Timepoint 225-235 minutes Amount consumed (kcal)
Plasma concentrations of GLP-1 Timepoint -95 to 180 minutes bsAUC
Plasma concentrations of peptide YY Timepoint -95 to 180 minutes bsAUC
Plasma concentrations of secretin Timepoint -95 to 180 minutes bsAUC
Circulating levels of P1NP Timepoint -95 to 180 minutes bsAUC
Gallbladder volume Timepoint -120 to 180 minutes Time to nadir (min)
Plasma concentrations of glucagon Timepoint -95 to 180 minutes bsAUC
Plasma concentrations of GIP Timepoint -95 to 180 minutes bsAUC
Plasma concentrations of leptin Timepoint -95 to 180 minutes bsAUC
Plasma concentrations of ghrelin Timepoint -95 to 180 minutes bsAUC
Circulating levels of CTx Timepoint -95 to 180 minutes bsAUC
Circulating levels of PTH Timepoint -95 to 180 minutes bsAUC
Circulating levels of calcium Timepoint -95 to 180 minutes bsAUC
Desire for specific foods Timepoint -100 to 160 minutes VAS (0-100 mm). bsAUC
Duration of ad libitum meal Timepoint 190-220 minutes Minutes
Happiness (Oxford Happiness Questionnaire (translated to Danish)) Timepoint -65 and 160 minutes Points on scale from 29-174
Trial Locations
- Locations (1)
Center for Clinical Metabolisk Research
🇩🇰Hellerup, Denmark