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

NCT06972238 | Not Yet Recruiting

• 1 other identifier: B02533
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pancreatitis, Acute; Hyperglycaemia

Keywords

Pancreatitis; Hyperglycaemia; inflammation; clinical severity; beta-cell

Outcome Measures

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

  28 days

Secondary Outcomes (3)

• Endogenous beta-cell insulin secretion

  28 days

• Bacterial endotoxin levels

  28 days

• Clinical severity of acute pancreatitis

  28 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Age 18 years or over
• Admission diagnosis of acute pancreatitis (based on Revised Atlanta Criteria)
• Ability to provide informed consent in English

You may not qualify if:

• Known diabetes mellitus
• Use of insulin therapy before admission
• Pregnancy
• Contraindications to CGM (e.g., allergy to device adhesive)

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

MeSH Terms

Conditions

Pancreatitis; Hyperglycemia; Inflammation

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hood M Thabit

  Manchester Royal Infirmary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hood Thabit, MD PhD

CONTACT

00441612766703; hood.thabit@mft.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 14, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 12 months following study completion.
• Access Criteria: Following reasonable request to the researcher by email.