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

Launched by UNIVERSITY HOSPITAL, GENTOFTE, COPENHAGEN · Mar 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how oxytocin, a hormone, affects the body's response to low blood sugar (hypoglycemia) in men with Type 1 Diabetes (T1D). The researchers want to see if oxytocin can help improve the release of glucagon, a hormone that helps raise blood sugar levels during hypoglycemic episodes. This is important because managing low blood sugar is a critical part of living with T1D.

To participate in this trial, men aged 18 to 75 with T1D may be eligible if they have had the condition for at least 3 years but no more than 30 years, and their blood sugar control is within certain limits. They must also have a stable insulin treatment plan for at least 3 months. Participants will receive more information about the trial procedures, which may include monitoring their blood sugar levels and other health assessments. If you meet the criteria and are interested, this study could provide valuable insights into better managing low blood sugar in T1D.

Gender

MALE

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