Stimulated Glucagon As a Biomarker of Hypoglycemic Risk in Type 1 Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

Type 1 diabetes (T1D) results from destruction of insulin producing beta cells by the body's own immune system (autoimmunity) causing an individual to lose the ability to make enough insulin to control their blood sugar levels and need to have insulin injections to lower blood glucose levels. Whilst high blood sugar level is a problem for people with Type 1 diabetes, taking insulin medication to lower sugar levels, delayed meals and exercise can all result in dangerously low blood sugar levels (hypoglycaemia). The biological causes of hypoglycaemia, and ways to prevent it are poorly understood. In non-diabetic individuals, a hormone called glucagon is secreted naturally to raise blood glucose levels but it is unclear why glucagon secretion is impaired during hypoglycaemia in individuals with T1D. The aim of this prospective observational study is to test the relationship between a glucagon stimulation test and risk of hypoglycaemia in T1D. It is hoped this research will establish whether this relationship could be used as a blood test and be a clinically useful biomarker of hypoglycaemia risk and, therefore, directly inform clinical care of people with T1D, particularly those with highest risk of hypoglycaemia. Assessment of beta cell decline has traditionally relied on timed C-peptide measures following a standardised liquid meal known as the mixed meal tolerance test (MMTT). Home finger prick blood spot C-peptide measurement might be a practical, cheap, and non-invasive alternative to a MMTT and would allow regular assessment of beta cell function over time. If proven that this sample type is a robust alternative to the gold standard MMTT venous C-peptide, it would dramatically decrease the cost and participant burden of T1D research into beta cell function.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
United Kingdom
Royal Devon University Healthcare NHS Foundation Trust
RECRUITING
Exeter
Contact Information
Primary
Richard A Oram, MRCP (neph)
r.oram@exeter.ac.uk
+44 (0) 1392 408538
Backup
Michelle Hudson, BSc
m.hudson@exeter.ac.uk
+44 (0) 1392 408181
Time Frame
Start Date: 2023-03-23
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 75
Treatments
MMTT Visit 1, AST Visit 2
Mixed Meal Tolerance Test (MMTT) Visit 1 and Arginine Stimulated Test (AST) Visit 2
AST Visit 1, MMTT Visit 2
Arginine Stimulated Test (AST) Visit 1 and Mixed Meal Tolerance Test (MMTT) Visit 2
Related Therapeutic Areas
Sponsors
Leads: University of Exeter
Collaborators: Royal Devon and Exeter NHS Foundation Trust

This content was sourced from clinicaltrials.gov