The Role of Oxytocin in Regulating Blood Glucose

Glucose Metabolism Disorders (Including Diabetes Mellitus) Clinical Trial

— GLOXY-1  

Official title:

The Role of Oxytocin in Regulating Blood Glucose

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06334172
• Other study ID #: H-23071221
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: University Hospital, Gentofte, Copenhagen
• Contact: Vivian Kliim-Hansen, MD
• Phone: +4524476875
• Email: vivian.kliim-hansen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Metabolism Disorders
• Glucose Metabolism Disorders (Including Diabetes Mellitus)
• Metabolic Diseases

Intervention

Drug:
• Oxytocin
Oxytocin

Other:
• Placebo
Saline

Locations

Country	Name	City	State
Denmark	Center for Clinical Metabolic Research, Gentofte Hospital	Hellerup	Capital Region

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin secretion - c-peptide	Insulin secretion, measured as percentual increase of area under the curve (AUC) for circulating c-peptide	From time 0 to time 180 min
Secondary	Glucose	measured as percentual increase of AUC for circulating levels	From time 0 minutes to time 180 minutes
Secondary	Insulin	measured as percentual increase of AUC for circulating levels	From time 0 minutes to time 180 minutes
Secondary	Glucagon	measured as percentual increase of AUC for circulating levels	From time 0 minutes to time 180 minutes
Secondary	GIP	measured as percentual increase of AUC for circulating levels	From time 0 minutes to time 180 minutes
Secondary	GLP-1	measured as percentual increase of AUC for circulating levels	From time 0 minutes to time 180 minutes
Secondary	Lipids	measured as percentual increase of AUCfor circulating levels	From time 0 minutes to time 180 minutes
Secondary	Cross-linked C-telopeptide of type I collagen( CTX)	measured as percentual increase of AUC for circulating levels	From time 0 minutes to time 180 minutes
Secondary	Procollagen type I N-terminal propeptide (P1NP)	measured as percentual increase of AUC for circulating levels	From time 0 minutes to time 180 minutes