The Role of Oxytocin in Regulating Blood Glucose

NCT06334172 | Recruiting

• 1 other identifier: H-23071221
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glucose Metabolism Disorders (Including Diabetes Mellitus)

Keywords

oxytocin; blood glucose; glucose stabilization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Glucose

  From time 0 minutes to time 180 minutes

• Insulin

  From time 0 minutes to time 180 minutes

• Glucagon

  From time 0 minutes to time 180 minutes

• GIP

  From time 0 minutes to time 180 minutes

• GLP-1

  From time 0 minutes to time 180 minutes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Infusion of placebo

Other: Placebo

Oxytocin 0.1 IU/min

EXPERIMENTAL

Infusion of oxytocin 0.1 IU/min

Drug: Oxytocin

Oxytocin 0.2 IU/min

EXPERIMENTAL

Infusion of oxytocin 0.2 IU/min

Drug: Oxytocin

Interventions

Oxytocin DRUG

Oxytocin

Oxytocin 0.1 IU/min; Oxytocin 0.2 IU/min

Placebo OTHER

Saline

Placebo

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• BMI 19-25 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead

Study Sites (1)

Center for Clinical Metabolic Research, Gentofte Hospital

Hellerup, Capital Region, 2900, Denmark

RECRUITING

MeSH Terms

Conditions

Glucose Metabolism Disorders

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Vivian Kliim-Hansen, MD

CONTACT

+4524476875; vivian.kliim-hansen@regionh.dk

Filip Krag Knop

CONTACT

filip.krag.knop.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The randomized order of infusions is blinded to both participant and investigator
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized, double-blinded, single-arm study. Each participant goes through three experimental days in a randomized order - acting as their own controls

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 27, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)