Glucose Levels in Acute Pancreatitis and the Impact of Insulin Depletion and Bacterial Endotoxaemia

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorManchester University NHS Foundation Trust

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
28 days

Secondary outcomes

1

Endogenous beta-cell insulin secretion

Plasma c-peptide

Time frame
28 days
2

Bacterial endotoxin levels

Plasma bacteria endotoxin

Time frame
28 days
3

Clinical severity of acute pancreatitis

BISAP Score

Time frame
28 days

Other outcomes

Locations

This trial has no 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: