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

NCT ID: NCT06881459

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-25
• Study Completion Date: 2025-09-01

Brief Summary

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

Detailed Description

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Infusion of placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Saline

Infusion of oxytocin

Infusion of oxytocin

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

Oxytocin

Interventions

Placebo

Saline

Intervention Type: OTHER

Oxytocin

Oxytocin

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Asger Lund, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Center for Clinical Metabolic Research, Gentofte Hospital

Hellerup, , Denmark

Countries

Denmark

Other Identifiers

H-24080204

Identifier Type: OTHER

Identifier Source: secondary_id

GLOXY-2

Identifier Type: -

Identifier Source: org_study_id