The Role of Oxytocin in Regulating Blood Glucose

Not Applicable

Recruiting

• Conditions: Glucose Metabolism Disorders (Including Diabetes Mellitus)
• Interventions: Other: Placebo; Drug: Oxytocin

• Registration Number: NCT06334172
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

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.

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2024-03-08
• Study First Submitted QC: 2024-03-20
• Study First Posted: 2024-03-27
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-04
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Infusion of placebo
Oxytocin 0.1 IU/min	Oxytocin	Infusion of oxytocin 0.1 IU/min
Oxytocin 0.2 IU/min	Oxytocin	Infusion of oxytocin 0.2 IU/min

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Glucose	From time 0 minutes to time 180 minutes	measured as percentual increase of AUC for circulating levels
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
GLP-1	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

Trial Locations

Locations (1)

Center for Clinical Metabolic Research, Gentofte Hospital; 🇩🇰 Hellerup, Capital Region, Denmark