Investigating how oxytocin affects glucagon response during low blood sugar in type 1 diabetes patients
The Effect of Oxytocin on the Alpha Cell Response to Hypoglycaemia in Patients with Type 1 Diabetes
This study is testing if giving oxytocin can help people with type 1 diabetes better manage their blood sugar levels during low blood sugar episodes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Male |
| Sponsor | University Hospital, Gentofte, Copenhagen Academic / other |
| Locations | 1 site (Hellerup) |
| Trial ID | NCT06881459 on ClinicalTrials.gov |
What this trial studies
This study examines the impact of oxytocin on glucagon secretion during hypoglycemia in individuals with type 1 diabetes. Sixteen participants will undergo a hypoglycemic clamp while receiving either synthetic oxytocin or a placebo in a randomized, double-blinded manner. The study aims to assess changes in various plasma and serum concentrations, including insulin and glucagon, to understand oxytocin's glucagonotropic effects. The findings could provide insights into new treatment approaches for managing hypoglycemia in type 1 diabetes.
Who should consider this trial
Good fit: Ideal candidates are individuals with type 1 diabetes, aged 18-65, with a stable insulin regimen and specific health criteria.
Not a fit: Patients with significant comorbidities, such as liver or kidney disease, or those on glucose-lowering medications other than insulin may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for hypoglycemia in patients with type 1 diabetes.
How similar studies have performed: While the specific effects of oxytocin on glucagon response in type 1 diabetes are less explored, related studies on oxytocin's role in metabolic regulation suggest potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hellerup
- Center for Clinical Metabolic Research, Gentofte Hospital — Hellerup, Denmark (Recruiting)
Study contacts
- Study coordinator: Vivian Kliim-Hansen, MD
- Email: vivian.kliim-hansen@regionh.dk
- Phone: +45 21306042
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.