The Effect of Oxytocin on the Alpha Cell Response to Hypoglycaemia in Patients With Type 1 Diabetes (GLOXY-2)

University Hospital, Gentofte, Copenhagen

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Other: Placebo; Drug: Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT06881459

H-24080204 (Other Identifier)

GLOXY-2

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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16 participants in 2 patient groups, including a placebo group

Infusion of placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo

Infusion of oxytocin

Experimental group

Description:

Infusion of oxytocin

Treatment:

Drug: Oxytocin