Status:
COMPLETED
The Effect of Oxytocin on the Alpha Cell Response to Hypoglycaemia in Patients With Type 1 Diabetes
Lead Sponsor:
University Hospital, Gentofte, Copenhagen
Conditions:
Type 1 Diabetes
Eligibility:
MALE
18-70 years
Phase:
NA
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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2025
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06881459
Start Date
March 25 2025
End Date
September 1 2025
Last Update
September 9 2025
Active Locations (1)
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1
Center for Clinical Metabolic Research, Gentofte Hospital
Hellerup, Denmark, 2900