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Investigating the effect of oxytocin on pancreatic endocrine functions by determining insulin and glucagon secretion within physiological ranges of plasma glucose.
Insulinotropic effects of oxytocin will be examined in 20 healthy men with body mass index (BMI) < 27 kg/m2, during a graded glucose infusion test with concomitant intravenous infusion of synthetic oxytocin or placebo in a randomized, double-blinded design. This will determine the effect of oxytocin on glucose-stimulated insulin and glucagon secretion. Additional changes in plasma/serum concentrations of C-peptide, glucose, glucose-dependent insulinotropic polypeptid (GIP), glucagon-like peptide 1 (GLP-1), and lipids will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Infusion of placebo |
|
| Oxytocin 0.1 IU/min | Experimental | Infusion of oxytocin 0.1 IU/min |
|
| Oxytocin 0.2 IU/min | Experimental | Infusion of oxytocin 0.2 IU/min |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | Oxytocin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin secretion - c-peptide | Insulin secretion, measured as percentual increase of area under the curve (AUC) for circulating c-peptide | From time 0 to time 180 min |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose | measured as percentual increase of AUC for circulating levels | From time 0 minutes to time 180 minutes |
| Insulin | measured as percentual increase of AUC for circulating levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vivian Kliim-Hansen, MD | Contact | +4524476875 | vivian.kliim-hansen@regionh.dk | |
| Filip Krag Knop | Contact | filip.krag.knop.01@regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Clinical Metabolic Research, Gentofte Hospital | Recruiting | Hellerup | Capital Region | 2900 | Denmark |
All published data will be made available to other researchers upon reasonable request
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| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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Randomized, double-blinded, single-arm study. Each participant goes through three experimental days in a randomized order - acting as their own controls
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The randomized order of infusions is blinded to both participant and investigator
| Placebo |
| Other |
Saline |
|
| From time 0 minutes to time 180 minutes |
| Glucagon | measured as percentual increase of AUC for circulating levels | From time 0 minutes to time 180 minutes |
| GIP | measured as percentual increase of AUC for circulating levels | From time 0 minutes to time 180 minutes |
| GLP-1 | measured as percentual increase of AUC for circulating levels | From time 0 minutes to time 180 minutes |
| Lipids | measured as percentual increase of AUCfor circulating levels | From time 0 minutes to time 180 minutes |
| Cross-linked C-telopeptide of type I collagen( CTX) | measured as percentual increase of AUC for circulating levels | From time 0 minutes to time 180 minutes |
| Procollagen type I N-terminal propeptide (P1NP) | measured as percentual increase of AUC for circulating levels | From time 0 minutes to time 180 minutes |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |