About this trial
There are currently no early predictive biomarkers for severity of acute pancreatitis (AP) that would allow stratification of patients for potential early interventional therapies. Hyperglycaemia is frequently observed to accompany and contribute to severe AP. However, the underlying mechanism is multifactorial, including in the acute phase of injury, where elevated adrenaline, cortisol and glucagon and inflammatory cytokine-induced insulin resistance all contribute to hyperglycaemia. The investigators propose that the extent of collateral injury of pancreatic β-cells and consequent loss of insulin secretion during the course of acute pancreatitis (AP) underlies disease severity. The investigators will measure plasma C-peptide (as a reliable readout of endogenous insulin), with moment-to-moment glucose monitoring (using subcutaneous continuous glucose monitoring devices), and bacterial endotoxin (lipopolysaccharide (LPS) in a prospective cohort of 30 severe AP patient blood samples taken every 5 days for up to 5 weeks of hospitalization.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or over
Admission diagnosis of acute pancreatitis (based on Revised Atlanta Criteria)
Ability to provide informed consent in English
Disqualifiers
Known diabetes mellitus
Use of insulin therapy before admission
Pregnancy
Contraindications to CGM (e.g., allergy to device adhesive)
Trial population
The study will be conducted on the surgical and medical wards at Manchester Royal Infirmary, (Manchester University NHS Foundation Trust \[MFT\]). Adults with acute pancreatitis will be recruited following admission to hospital under the treating clinical team. Patients will be identified by a member of the usual clinical team based upon analysis of the acute surgical take on our electronic health record (HIVE), cross referencing abdominal pain and raised lipase and imaging when appropriate.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Time in range
The primary outcome is time spent in normal range (3.9 - 10.0 mmol/l) based on CGM sensor glucose levels during inpatient stay
Secondary outcomes
Endogenous beta-cell insulin secretion
Plasma c-peptide
Bacterial endotoxin levels
Plasma bacteria endotoxin
Clinical severity of acute pancreatitis
BISAP Score
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: