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

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

Study Overview

• Status: Recruiting
• Conditions: Glucose Metabolism Disorders (Including Diabetes Mellitus)
• Intervention / Treatment: Other: Placebo; Drug: Oxytocin

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vivian Kliim-Hansen, MD; Phone Number: +4524476875; Email: vivian.kliim-hansen@regionh.dk
• Study Contact Backup: Name: Filip Krag Knop; Email: filip.krag.knop.01@regionh.dk

Study Locations

• Denmark
  • Capital Region
    • Hellerup, Capital Region, Denmark, 2900
      • Recruiting
      • Center for Clinical Metabolic Research, Gentofte Hospital
      • Contact: Filip K Knop, MD, PhD; Phone Number: 004538674266; Email: filip.krag.knop.01@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Infusion of placebo	Other: Placebo; Saline
Experimental: Oxytocin 0.1 IU/min; Infusion of oxytocin 0.1 IU/min	Drug: Oxytocin; Oxytocin
Experimental: Oxytocin 0.2 IU/min; Infusion of oxytocin 0.2 IU/min	Drug: Oxytocin; Oxytocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose	measured as percentual increase of AUC for circulating levels	From time 0 minutes to time 180 minutes
Insulin	measured as percentual increase of AUC for circulating levels	From time 0 minutes to time 180 minutes
Glucagon	measured as percentual increase of AUC for circulating levels	From time 0 minutes to time 180 minutes
GIP	measured as percentual increase of AUC for circulating levels	From time 0 minutes to time 180 minutes
GLP-1	measured as percentual increase of AUC for circulating levels	From time 0 minutes to time 180 minutes
Lipids	measured as percentual increase of AUCfor circulating levels	From time 0 minutes to time 180 minutes
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
Procollagen type I N-terminal propeptide (P1NP)	measured as percentual increase of AUC for circulating levels	From time 0 minutes to time 180 minutes

Collaborators and Investigators

• Sponsor: University Hospital, Gentofte, Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 8, 2024
• First Submitted That Met QC Criteria: March 20, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: oxytocin; blood glucose; glucose stabilization
• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: H-23071221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All published data will be made available to other researchers upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No