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

NCT06881459 | Completed

• 2 other identifiers: GLOXY-2H-24080204
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Glucagon secretion

  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

  From time 30 to time 90 minutes

Secondary Outcomes (11)

• Glucagon during recovery

  From time 90 minutes to time 135 minutes

• Glucagon during the entire period

  From time 0 minutes to time 135 minutes

• Glucose infusion

  From time 0 minutes to time 135 minutes

• Insulin

  From time 0 minutes to time 135 minutes

• c-peptide

  From time 0 minutes to time 135 minutes

Study Arms (2)

Infusion of placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Infusion of oxytocin

EXPERIMENTAL

Infusion of oxytocin

Drug: Oxytocin

Interventions

Placebo OTHER

Saline

Infusion of placebo

Oxytocin DRUG

Oxytocin

Infusion of oxytocin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead

Study Sites (1)

Center for Clinical Metabolic Research, Gentofte Hospital

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The randomized order of infusions is blinded to both participant and investigator
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized, double-blinded, single-arm study. Each participant goes through two experimental days in a randomized order, acting as their own controls

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 18, 2025
• Study Start: March 25, 2025
• Primary Completion: July 18, 2025
• Study Completion: September 1, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)