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
Organization
University Hospital of CopenhagenProduct
OxytocinIndication
Diabetes Mellitus