Skip to main content
OpenTrials
Completed

NCT Number: NCT06881459

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Center for Clinical Metabolic Research, Gentofte Hospital

Hellerup, 2900, Denmark

About this study

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 can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body mass index from 19 to 30 kg/m2
  • T1D (diagnosed according to the criteria of the World Health Organization) with HbA1c <69 mmol/mol (<8.5%)
  • T1D duration of 3-30 years
  • C-peptide negative (stimulated C-peptide ≤ 100 pmol/l)
  • Treatment with a stable basal-bolus or insulin pump regimen for ≥3 months

Exclusion criteria

  • 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)
  • Late microvascular complications except mild non-proliferative retinopathy
  • Regular tobacco smoking or use of other nicotine-containing products
  • Long QTc on electrocardiogram (ECG) at screening (≥0.45 seconds)
  • Pituitary gland disease
  • Treatment with any glucose-lowering drugs besides insulin
  • Any ongoing medication or physical or psychological condition that the investigator feels would interfere with trial participation

Treatment and study plan

Placebo

Other

Saline

Oxytocin

Drug

Oxytocin

Primary outcomes

  1. Glucagon secretion

    Time frame: From time 30 to time 90 minutes

    Glucagon secretion, measured as the difference in plasma glucagon response to hypoglycaemia (as assessed by baseline subtracted area under curve (bsAUC)) during the hypoglycaemic clamp, between study days with oxytocin and with placebo

Secondary outcomes

  1. Glucagon during recovery

    Time frame: From time 90 minutes to time 135 minutes

    measured as difference in glucagon bsAUC in the recovery phase

  2. Glucagon during the entire period

    Time frame: From time 0 minutes to time 135 minutes

    measured as difference in glucagon bsAUC in the intire period

  3. Glucose infusion

    Time frame: From time 0 minutes to time 135 minutes

    measured as the total amount of glucose infused

  4. Insulin

    Time frame: From time 0 minutes to time 135 minutes

    measured as the difference in circulating levels of insulin between study days

  5. c-peptide

    Time frame: From time 0 minutes to time 135 minutes

    measured as the difference in circulating levels of c-peptide between study days

  6. Epinephrine

    Time frame: From time 0 minutes to time 135 minutes

    measured as the difference in circulating levels of epinephrine between study days

  7. Norepinephrine

    Time frame: From time 0 minutes to time 135 minutes

    measured as the difference in circulating levels of norepinephrine between study days

  8. Cortisol

    Time frame: From time 0 minutes to time 135 minutes

    measured as the difference in circulating levels of cortisol between study days

  9. Cross-linked C-telopeptide of type I collagen( CTX)

    Time frame: From time 0 minutes to time 135 minutes

    measured as the difference in circulating levels of CTX between study days

  10. Procollagen type I N-terminal propeptide (P1NP)

    Time frame: From time 0 minutes to time 135 minutes

    measured as the difference in circulating levels of P1NP between study days

  11. Growth Hormone (GH)

    Time frame: From time 0 minutes to time 135 minutes

    measured as the difference in circulating levels of GH between study days

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Acronym: GLOXY-2

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 18, 2025
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.