Adiposity
Conditions
Keywords
oxytocin, appetite regulation, gastrointestinal motility, energy expenditure
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.
Interventions
DRUGOxytocin
Intravenous oxytocin 0.2 IU/min during experimental days
OTHERPlacebo (saline)
Intravenous saline during experimental days
Sponsors
University Hospital, Gentofte, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ad libitum food intake | Timepoint 190-220 minutes | Amount consumed (kcal) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ad libitum food intake | Timepoint 190-220 minutes | Amount consumed (kcal/kg) |
| Sensations of hunger | Timepoint -100 to 160 minutes | Visual analogue score (VAS) (0-100 mm) (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) |
| 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) |
| Plasma concentrations of glucose | Timepoint -95 to 180 minutes | Baseline |
| Serum concentrations of insulin | Timepoint -95 to 180 minutes | Baseline |
| Serum concentrations of C-peptide | Timepoint -95 to 180 minutes | Baseline |
| Beta cell function (C-peptide/glucose-ratio) | Timepoint -95 to 180 minutes | Baseline |
| Plasma concentrations of cholecystokinin | Timepoint -95 to 180 minutes | Baseline |
| Energy expenditure (indirect calorimetry) | Timepoint -90 to 150 minutes | Resting energy expenditure (REE) |
| Snacking (ad libitum snack test) | Timepoint 225-235 minutes | Amount consumed (kcal) |
| Gallbladder volume (ml) | Timepoint -120 to 180 minutes | Baseline |
| Gallbladder ejection fraction (%) | Timepoint -120 to 180 minutes | GBEF% |
| Gallbladder volume | Timepoint -120 to 180 minutes | Time to nadir (min) |
| Plasma concentrations of glucagon | Timepoint -95 to 180 minutes | Baseline |
| Plasma concentrations of GLP-1 | Timepoint -95 to 180 minutes | Baseline |
| Plasma concentrations of GIP | Timepoint -95 to 180 minutes | Baseline |
| Plasma concentrations of peptide YY | Timepoint -95 to 180 minutes | Baseline |
| Plasma concentrations of leptin | Timepoint -95 to 180 minutes | Baseline |
| Plasma concentrations of ghrelin | Timepoint -95 to 180 minutes | Baseline |
| Plasma concentrations of secretin | Timepoint -95 to 180 minutes | Baseline |
| Gastric emptying (paracetamol absorption method) | Timepoint -95 to 180 minutes | Baseline |
| Circulating levels of total amino acids | Timepoint -95 to 180 minutes | Baseline |
| Lipid profile | Timepoint -95 to 180 minutes | Baseline |
| Circulating levels of CTx | Timepoint -95 to 180 minutes | Baseline |
| Circulating levels of P1NP | Timepoint -95 to 180 minutes | Baseline |
| Circulating levels of PTH | Timepoint -95 to 180 minutes | Baseline |
| Circulating levels of calcium | Timepoint -95 to 180 minutes | Baseline |
| Desire for specific foods | Timepoint -100 to 160 minutes | VAS (0-100 mm). Baseline |
| Duration of ad libitum meal | Timepoint 190-220 minutes | Minutes |
| Water intake during ad libitum meal | Timepoint 190-220 minutes | ml |
| Blood pressure | Timepoint -75 to 185 minutes and timpoint 240 minutes | Baseline |
| Heart rate | Timepoint -75 to 185 minutes and timpoint 240 minutes | Baseline |
| Plasma concentrations of creatinine | Timepoint -95 and 235 minutes | Baseline |
| Sensations of prospective food intake | Timepoint -100 to 160 minutes | Visual analogue score (VAS) (0-100 mm) (bsAUC) |
| Plasma concentrations of sodium | Timepoint -95 and 235 minutes | Baseline |
| Happiness (Oxford Happiness Questionnaire (translated to Danish)) | Timepoint -65 and 160 minutes | Points on scale from 29-174 |
| 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 |
| Plasma concentrations of potassium | Timepoint -95 and 235 minutes | Baseline |
Countries
Denmark
Outcome results
None listed