Clinical trial

The Role of Oxytocin in Regulating Blood Glucose

Name
H-23071221
Description
Investigating the effect of oxytocin on pancreatic endocrine functions by determining insulin and glucagon secretion within physiological ranges of plasma glucose.
Trial arms
Trial start
2024-01-01
Estimated PCD
2026-12-31
Trial end
2026-12-31
Status
Recruiting
Treatment
Oxytocin
Oxytocin
Arms:
Oxytocin 0.1 IU/min, Oxytocin 0.2 IU/min
Placebo
Saline
Arms:
Placebo
Size
20
Primary endpoint
Insulin secretion - c-peptide
From time 0 to time 180 min
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized, double-blinded, single-arm study. Each participant goes through three experimental days in a randomized order - acting as their own controls', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'The randomized order of infusions is blinded to both participant and investigator', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}
Updated at
2024-04-04

1 organization

1 product

1 indication

Product
Oxytocin