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The Role of Oxytocin in Regulating Blood Glucose

Plain-language guide to NCT06334172: not phased randomized trial of Oxytocin, 20 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06334172
Phase
not phased
Status
recruiting participants
Start
2024-01-01
Completion (planned or actual)
2026-12-31
Participants
20 (estimated)
Design
randomized, double-blind, basic_science
Conditions studied
Glucose Metabolism Disorders (Including Diabetes Mellitus)
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Oxytocin.

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

It had three arms (groups): Placebo (placebo comparator), one (experimental) and one (experimental).

Infusion of placebo.

The registry classes the interventions as drug and other.

More on the Plan

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.

Who Took Part

Enrollment: 20 planned participants were the target.

It was open to men only aged from 20 years up to 50 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: BMI 19-25 kg/m2.

The full record lists 1 inclusion and 11 exclusion criteria; among the exclusions: heart-, liver or kidney disease; smoking or any kind of nicotine products; alanin aminotransferase (alat) ≥ 2 × normal range.

How the Study Was Run

Design: randomized, crossover and double-blind.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Oxytocin and the comparison in turn, acting as their own control.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant and investigator.

It started in 2024-01-01 with completion listed for 2026-12-31.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Insulin secretion - c-peptide (time frame: From time 0 to time 180 min).

It also tracked 8 secondary outcomes, for example Glucose, Insulin, Glucagon, GIP, GLP-1 and Lipids.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 20 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.

Our Notes on the Compound

Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.