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Recruiting NCT06334172

The Role of Oxytocin in Regulating Blood Glucose

No phase Interventional Glucose Metabolism Disorders (Including Diabetes Mellitus)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oxytocin, Placebo.
Who it may be relevant to
Registry conditions: Glucose Metabolism Disorders (Including Diabetes Mellitus). Basic parameters: 20 years — 50 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Drug Oxytocin
    Oxytocin
  • Other Placebo
    Saline

Primary outcome measures

  • Insulin secretion - c-peptide [Time frame: From time 0 to time 180 min]
Secondary outcome measures (8)
  • Glucose [Time frame: From time 0 minutes to time 180 minutes]
  • Insulin [Time frame: From time 0 minutes to time 180 minutes]
  • Glucagon [Time frame: From time 0 minutes to time 180 minutes]
  • GIP [Time frame: From time 0 minutes to time 180 minutes]
  • GLP-1 [Time frame: From time 0 minutes to time 180 minutes]
  • Lipids [Time frame: From time 0 minutes to time 180 minutes]
  • Cross-linked C-telopeptide of type I collagen( CTX) [Time frame: From time 0 minutes to time 180 minutes]
  • Procollagen type I N-terminal propeptide (P1NP) [Time frame: From time 0 minutes to time 180 minutes]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Basic science

Study locations

Denmark · 1 center
  • Center for Clinical Metabolic Research, Gentofte Hospital — Hellerup

Identifiers

NCT: NCT06334172 · H-23071221

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗