Testing glucagon levels to understand hypoglycemia risk in Type 1 diabetes
Stimulated Glucagon As a Biomarker of Hypoglycemic Risk in Type 1 Diabetes
This study is trying to see if measuring glucagon levels can help predict the risk of low blood sugar in people with Type 1 diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 16 Years to 65 Years |
| Sex | All |
| Sponsor | University of Exeter Academic / other |
| Locations | 1 site (Exeter, Devon) |
| Trial ID | NCT05616273 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between glucagon secretion and the risk of hypoglycemia in individuals with Type 1 diabetes. Participants will undergo a Mixed Meal Tolerance Test (MMTT) and an Arginine Stimulation Test (AST) to measure their glucagon levels after meals. The study seeks to determine if low glucagon levels can serve as a biomarker for predicting hypoglycemia risk, thereby improving patient management. Participants will be informed about the study and their rights before consenting to take part.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 16-65 with a clinical diagnosis of Type 1 diabetes who are insulin-treated.
Not a fit: Patients under 16 or over 65 years old, pregnant or lactating women, and those with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to better identification of individuals at high risk for hypoglycemia, allowing for improved management and prevention strategies.
How similar studies have performed: While the specific approach of using glucagon as a biomarker is novel, similar studies have explored glucagon's role in diabetes management with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical diagnosis of Type 1 diabetes * Insulin treated * Known urine C-peptide status (using Urinary C-Peptide Creatinine Ratio \[UCPCR\], positive/negative defined by UCPCR 0.2nmol/mmol cut-off) * Age 16-65 years inclusive * Able and willing to provide informed consent/assent. Exclusion Criteria: * Age less than 16 year or over 65 years * Pregnant or lactating (as this may limit blood sampling and affect T cell function) * Any medical condition that, in the opinion of the investigator, would affect the safety of the subject's participation, or validity of results.
Where this trial is running
Exeter, Devon
- Royal Devon University Healthcare NHS Foundation Trust — Exeter, Devon, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Richard A Oram, MRCP (neph) — University of Exeter
- Study coordinator: Richard A Oram, MRCP (neph)
- Email: r.oram@exeter.ac.uk
- Phone: +44 (0) 1392 408538
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.