Glucose Metabolism Disorders (Including Diabetes Mellitus)
Conditions
Keywords
oxytocin, blood glucose, glucose stabilization
Brief summary
Investigating the effect of oxytocin on pancreatic endocrine functions by determining insulin and glucagon secretion within physiological ranges of plasma glucose.
Detailed description
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.
Interventions
DRUGOxytocin
Oxytocin
OTHERPlacebo
Saline
Sponsors
University Hospital, Gentofte, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
The randomized order of infusions is blinded to both participant and investigator
Intervention model description
Randomized, double-blinded, single-arm study. Each participant goes through three experimental days in a randomized order - acting as their own controls
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* BMI 19-25 kg/m2
Exclusion criteria
* Diabetes * Heart-, liver or kidney disease * More than 14 units of alcohol weekly, or drug abuse * Smoking or any kind of nicotine products * Alanin aminotransferase (ALAT) ≥ 2 × normal range * Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1,73m2 or creatinine above normal range * Blood pressure \> 140/90 * Hemoglobin \< normal range * Corrected QT Interval (Qtc) \>0,45 sec. at electrocardiogram (ECG) at screening * Known disease in the pituitary gland or previous pituitary surgery * Any other disease/condition which the trial managers believe may affect participation in the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin secretion - c-peptide | From time 0 to time 180 min | Insulin secretion, measured as percentual increase of area under the curve (AUC) for circulating c-peptide |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin | From time 0 minutes to time 180 minutes | measured as percentual increase of AUC for circulating levels |
| Glucagon | From time 0 minutes to time 180 minutes | measured as percentual increase of AUC for circulating levels |
| GIP | From time 0 minutes to time 180 minutes | measured as percentual increase of AUC for circulating levels |
| Glucose | From time 0 minutes to time 180 minutes | measured as percentual increase of AUC for circulating levels |
| Lipids | From time 0 minutes to time 180 minutes | measured as percentual increase of AUCfor circulating levels |
| Cross-linked C-telopeptide of type I collagen( CTX) | From time 0 minutes to time 180 minutes | measured as percentual increase of AUC for circulating levels |
| Procollagen type I N-terminal propeptide (P1NP) | From time 0 minutes to time 180 minutes | measured as percentual increase of AUC for circulating levels |
| GLP-1 | From time 0 minutes to time 180 minutes | measured as percentual increase of AUC for circulating levels |
Countries
Denmark
Contacts
Primary ContactVivian Kliim-Hansen, MD
Backup ContactFilip Krag Knop
Outcome results
None listed