The Role of Oxytocin in Regulating Blood Glucose (GLOXY-1)

University Hospital, Gentofte, Copenhagen

Status: Enrolling

Conditions: Glucose Metabolism Disorders (Including Diabetes Mellitus)

Treatments: Drug: Oxytocin; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06334172

H-23071221

Details and patient eligibility

About

Investigating the effect of oxytocin on pancreatic endocrine functions by determining insulin and glucagon secretion within physiological ranges of plasma glucose.

Full 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.

Enrollment: 20 estimated patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Infusion of placebo

Treatment:

Other: Placebo

Oxytocin 0.1 IU/min

Experimental group

Description:

Infusion of oxytocin 0.1 IU/min

Treatment:

Drug: Oxytocin

Oxytocin 0.2 IU/min

Experimental group

Description:

Infusion of oxytocin 0.2 IU/min

Treatment:

Drug: Oxytocin