The Effect of Oxytocin on the Alpha Cell Response to Hypoglycaemia in Patients With Type 1 Diabetes

What Was Tested

This registered not phased trial tested Oxytocin.

Investigating the effect of oxytocin on pancreatic endocrine functions by determining glucagon secretion during hypoglycemia in participants with type 1 diabetes.

It had two arms (groups): Infusion of placebo (placebo comparator) and Infusion of oxytocin (experimental).

Placebo.

Infusion of oxytocin.

The registry classes the interventions as drug and other.

More on the Plan

Glucagonotropic effects of oxytocin will be examined in 16 participants with type 1 diabetes, during a hypoglycaemic clamp with concomitant intravenous infusion of synthetic oxytocin or placebo in a randomised, double-blinded design.

This will determine the effect of oxytocin on the glucagon response to hypoglycemia.

Additional changes in plasma/serum concentrations of insulin, C-peptide, glucose, glucose-dependent insulinotropic polypeptid (GIP) and glucagon-like peptide 1 (GLP-1) will be assessed.

Who Took Part

16 actual participants took part.

It was open to men only aged from 18 years up to 70 years.

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

Examples of who could join: Body mass index from 19 to 30 kg/m2. T1D duration of 3-30 years. Treatment with a stable basal-bolus or insulin pump regimen for ≥3 months.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: anaemia (haemoglobin below normal range); liver disease (alanine aminotransferase (alt) and/or aspartate aminotransferase (ast) \>2 times normal values) or present hepatobiliary and/or gastrointestinal disorder(s); kidney disease (serum creatinine above normal range).

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

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 2025-03-25 with completion listed for 2025-07-18.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Glucagon secretion (time frame: From time 30 to time 90 minutes).

It also tracked 11 secondary outcomes, for example Glucagon during recovery, Glucagon during the entire period, Glucose infusion, Insulin, c-peptide and Epinephrine.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 16 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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