Clinical trial NCT06881459: The Effect of Oxytocin on the Alpha Cell Response to Hypoglycaemia in Patients with Type 1 Diabetes
Official title: The Effect of Oxytocin on the Alpha Cell Response to Hypoglycaemia in Patients with Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, double-blinded, single-arm study. Each participant goes through two experimental days in a randomized order, acting as their own controls
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Glucagon secretion
timeFrame: From time 30 to time 90 minutes
Secondary outcomes:
measure: Glucagon during recovery
timeFrame: From time 90 minutes to time 135 minutes
measure: Glucagon during the entire period
timeFrame: From time 0 minutes to time 135 minutes
measure: Glucose infusion
timeFrame: From time 0 minutes to time 135 minutes
measure: Insulin
timeFrame: From time 0 minutes to time 135 minutes
measure: c-peptide
timeFrame: From time 0 minutes to time 135 minutes
measure: Epinephrine
timeFrame: From time 0 minutes to time 135 minutes
measure: Norepinephrine
timeFrame: From time 0 minutes to time 135 minutes
measure: Cortisol
timeFrame: From time 0 minutes to time 135 minutes
measure: Cross-linked C-telopeptide of type I collagen( CTX)
timeFrame: From time 0 minutes to time 135 minutes
measure: Procollagen type I N-terminal propeptide (P1NP)
timeFrame: From time 0 minutes to time 135 minutes
measure: Growth Hormone (GH)
timeFrame: From time 0 minutes to time 135 minutes
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Center for Clinical Metabolic Research, Gentofte Hospital
Study officials:
References: