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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin | Experimental | Intravenous oxytocin 0.2 IU/minute for 300 minutes Approx. 500 ml |
|
| Placebo | Other | intravenous saline (0.9% NaCl) infusion for 300 minutes Approx. 500 ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | Intravenous oxytocin 0.2 IU/min during experimental days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Ad libitum food intake | Amount consumed (kcal) | Timepoint 190-220 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Ad libitum food intake | Amount consumed (kcal/kg) | Timepoint 190-220 minutes |
| Sensations of hunger | Visual analogue score (VAS) (0-100 mm) (bsAUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Clinical Metabolisk Research | Hellerup | 2100 | Denmark |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Placebo (saline) |
| Other |
Intravenous saline during experimental days |
|
| Timepoint -100 to 160 minutes |
| Sensations of satiety | Visual analogue score (VAS) (0-100 mm) (bsAUC) | Timepoint -100 to 160 minutes |
| Sensations of fullness | Visual analogue score (VAS) (0-100 mm) (bsAUC) | Timepoint -100 to 160 minutes |
| Sensations of prospective food intake | Visual analogue score (VAS) (0-100 mm) (bsAUC) | Timepoint -100 to 160 minutes |
| Sensations of nausea | Visual analogue score (VAS) (0-100 mm) (bsAUC) | Timepoint -100 to 160 minutes |
| Sensations of thirst | Visual analogue score (VAS) (0-100 mm) (bsAUC) | Timepoint -100 to 160 minutes |
| Sensations of comfort | Visual analogue score (VAS) (0-100 mm) (bsAUC) | Timepoint -100 to 160 minutes |
| Composite appetite score | Calculated from VAS of hunger, fullness and prospective food intake (bsAUC) | Timepoint -100 to 160 |
| Plasma concentrations of glucose | Baseline | Timepoint -95 to 180 minutes |
| Plasma concentrations of glucose | bsAUC | Timepoint -95 to 180 minutes |
| Plasma concentrations of glucose | Peak value | Timepoint -95 to 180 minutes |
| Serum concentrations of insulin | Baseline | Timepoint -95 to 180 minutes |
| Serum concentrations of insulin | bsAUC | Timepoint -95 to 180 minutes |
| Serum concentrations of C-peptide | Baseline | Timepoint -95 to 180 minutes |
| Serum concentrations of C-peptide | bsAUC | Timepoint -95 to 180 minutes |
| Beta cell function (C-peptide/glucose-ratio) | Baseline | Timepoint -95 to 180 minutes |
| Beta cell function (C-peptide/glucose-ratio) | bsAUC | Timepoint -95 to 180 minutes |
| Plasma concentrations of cholecystokinin | Baseline | Timepoint -95 to 180 minutes |
| Plasma concentrations of cholecystokinin | bsAUC | Timepoint -95 to 180 minutes |
| Energy expenditure (indirect calorimetry) | Resting energy expenditure (REE) | Timepoint -90 to 150 minutes |
| Energy expenditure (indirect calorimetry) | Respiration exchange rate (RER) | Timepoint -90 to 150 minutes |
| Snacking (ad libitum snack test) | Amount consumed (kcal) | Timepoint 225-235 minutes |
| Gallbladder volume (ml) | Baseline | Timepoint -120 to 180 minutes |
| Gallbladder volume (ml) | AUC | Timepoint -120 to 180 minutes |
| Gallbladder ejection fraction (%) | GBEF% | Timepoint -120 to 180 minutes |
| Gallbladder volume (ml) | Nadir | Timepoint -120 to 180 minutes |
| Gallbladder volume | Time to nadir (min) | Timepoint -120 to 180 minutes |
| Plasma concentrations of glucagon | Baseline | Timepoint -95 to 180 minutes |
| Plasma concentrations of glucagon | bsAUC | Timepoint -95 to 180 minutes |
| Plasma concentrations of GLP-1 | Baseline | Timepoint -95 to 180 minutes |
| Plasma concentrations of GLP-1 | bsAUC | Timepoint -95 to 180 minutes |
| Plasma concentrations of GIP | Baseline | Timepoint -95 to 180 minutes |
| Plasma concentrations of GIP | bsAUC | Timepoint -95 to 180 minutes |
| Plasma concentrations of peptide YY | Baseline | Timepoint -95 to 180 minutes |
| Plasma concentrations of peptide YY | bsAUC | Timepoint -95 to 180 minutes |
| Plasma concentrations of leptin | Baseline | Timepoint -95 to 180 minutes |
| Plasma concentrations of leptin | bsAUC | Timepoint -95 to 180 minutes |
| Plasma concentrations of ghrelin | Baseline | Timepoint -95 to 180 minutes |
| Plasma concentrations of ghrelin | bsAUC | Timepoint -95 to 180 minutes |
| Plasma concentrations of secretin | Baseline | Timepoint -95 to 180 minutes |
| Plasma concentrations of secretin | bsAUC | Timepoint -95 to 180 minutes |
| Gastric emptying (paracetamol absorption method) | Baseline | Timepoint -95 to 180 minutes |
| Gastric emptying (paracetamol absorption method) | bsAUC | Timepoint -95 to 180 minutes |
| Circulating levels of total amino acids | Baseline | Timepoint -95 to 180 minutes |
| Circulating levels of total amino acids | bsAUC | Timepoint -95 to 180 minutes |
| Lipid profile | Baseline | Timepoint -95 to 180 minutes |
| Lipid profile | bsAUC | Timepoint -95 to 180 minutes |
| Circulating levels of CTx | Baseline | Timepoint -95 to 180 minutes |
| Circulating levels of CTx | bsAUC | Timepoint -95 to 180 minutes |
| Circulating levels of P1NP | Baseline | Timepoint -95 to 180 minutes |
| Circulating levels of P1NP | bsAUC | Timepoint -95 to 180 minutes |
| Circulating levels of PTH | Baseline | Timepoint -95 to 180 minutes |
| Circulating levels of PTH | bsAUC | Timepoint -95 to 180 minutes |
| Circulating levels of calcium | Baseline | Timepoint -95 to 180 minutes |
| Circulating levels of calcium | bsAUC | Timepoint -95 to 180 minutes |
| Desire for specific foods | VAS (0-100 mm). Baseline | Timepoint -100 to 160 minutes |
| Desire for specific foods | VAS (0-100 mm). bsAUC | Timepoint -100 to 160 minutes |
| Duration of ad libitum meal | Minutes | Timepoint 190-220 minutes |
| Water intake during ad libitum meal | ml | Timepoint 190-220 minutes |
| Blood pressure | Baseline | Timepoint -75 to 185 minutes and timpoint 240 minutes |
| Blood pressure | bsAUC | Timepoint -75 to 185 minutes and timpoint 240 minutes |
| Heart rate | Baseline | Timepoint -75 to 185 minutes and timpoint 240 minutes |
| Heart rate | bsAUC | Timepoint -75 to 185 minutes and timpoint 240 minutes |
| Plasma concentrations of creatinine | Baseline | Timepoint -95 and 235 minutes |
| Plasma concentrations of creatinine | End-infusion | Timepoint -95 and 235 minutes |
| Plasma concentrations of potassium | Baseline | Timepoint -95 and 235 minutes |
| Plasma concentrations of potassium | bsAUC | Timepoint -95 and 235 minutes |
| Plasma concentrations of sodium | Baseline | Timepoint -95 and 235 minutes |
| Plasma concentrations of sodium | End-infusion | Timepoint -95 and 235 minutes |
| Happiness (Oxford Happiness Questionnaire (translated to Danish)) | Points on scale from 29-174 | Timepoint -65 and 160 minutes |
| Circulating levels of high-sensitive C-reactive protein (hsCRP) | Baseline | Timepoint -95 and 235 minutes |
| Circulating levels of C-reactive protein (hsCRP) | End-infusion | Timepoint -95 and 235 minutes |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |