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

Not Applicable

Recruiting

• Conditions: Type 1 Diabetes
• Interventions: Other: Placebo; Drug: Oxytocin

• Registration Number: NCT06881459
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-11
• Study Start: 2025-03-25
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Infusion of placebo	Placebo	Placebo
Infusion of oxytocin	Oxytocin	Infusion of oxytocin

Primary Outcome Measures

Name	Time	Method
Glucagon secretion	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 Outcome Measures

Name	Time	Method
Glucagon during recovery	From time 90 minutes to time 135 minutes	measured as difference in glucagon bsAUC in the recovery phase
Glucagon during the entire period	From time 0 minutes to time 135 minutes	measured as difference in glucagon bsAUC in the intire period
Glucose infusion	From time 0 minutes to time 135 minutes	measured as the total amount of glucose infused
Insulin	From time 0 minutes to time 135 minutes	measured as the difference in circulating levels of insulin between study days
c-peptide	From time 0 minutes to time 135 minutes	measured as the difference in circulating levels of c-peptide between study days
Epinephrine	From time 0 minutes to time 135 minutes	measured as the difference in circulating levels of epinephrine between study days
Norepinephrine	From time 0 minutes to time 135 minutes	measured as the difference in circulating levels of norepinephrine between study days
Cortisol	From time 0 minutes to time 135 minutes	measured as the difference in circulating levels of cortisol between study days
Cross-linked C-telopeptide of type I collagen( CTX)	From time 0 minutes to time 135 minutes	measured as the difference in circulating levels of CTX between study days
Procollagen type I N-terminal propeptide (P1NP)	From time 0 minutes to time 135 minutes	measured as the difference in circulating levels of P1NP between study days
Growth Hormone (GH)	From time 0 minutes to time 135 minutes	measured as the difference in circulating levels of GH between study days

Trial Locations

Locations (1)

Center for Clinical Metabolic Research, Gentofte Hospital; 🇩🇰 Hellerup, Denmark