Endocrine and Exocrine Secretory Function Alterations After Moderately Severe and Severe Acute Pancreatitis

February 19, 2025 updated by: Tuo Li, MD, Shanghai Changzheng Hospital

Prospective Cohort Study on Endocrine and Exocrine Secretory Function Alterations After Moderately Severe and Severe Acute Pancreatitis

The goal of this observational study is to learn about post-acute pancreatitis diabetes mellitus (PPDM-A). The main questions it aims to answer are:

  1. Are the incident rates of glucose metabolic disorders (pre-diabetes and diabetes mellitus) after acute pancreatitis of different etiologies the same?
  2. Are alterations in endocrine and exocrine secretory function in patients with acute pancreatitis associated with all-round outcomes?

All patients with acute pancreatitis have been given the standardized treatment for the condition.

Investigators will compare the incident rates of glucose metabolic disorders (pre-diabetes and diabetes mellitus) after acute pancreatitis of different etiologies in patients with moderately severe (MSAP) and severe acute pancreatitis (SAP) to explore the association between alterations in endocrine and exocrine secretory function and all-round outcomes.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Investigators will prospectively collect data from patients with moderately severe (MSAP) and severe acute pancreatitis (SAP) in participant centers.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 20003
        • Shanghai Changzheng Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Investigators will collect data from patients with moderately severe (MSAP) and severe acute pancreatitis (SAP) in participant centers.

Description

Inclusion Criteria:

  1. Male or female Chinese subjects;
  2. Age ≥18 years at the time of signing the informed consent;
  3. Patients with a complete diagnosis of MSAP and SAP (according to the Chinese guidelines for the diagnosis and treatment of acute pancreatitis 2019);
  4. Voluntary signatories of informed consent

Exclusion Criteria:

  1. Patients with a history of diabetes mellitus or pre-diabetes mellitus, or glycosylated hemoglobin ≥ 6.0% or venous FPG ≥ 6.1 mmol/L at admission;
  2. Patients have any evidence of type 1 diabetes-related autoimmunity;
  3. Patients have any risk for secondary diabetes due to exposure to medications or other endocrine diseases;
  4. Combined with pancreas-related trauma or a history of pancreatic surgery;
  5. Patients undergo pancreatic surgery during treatment;
  6. Pregnancy or breastfeeding;
  7. Patients suffer from severe cardiac, hepatic or renal insufficiency or malignant diseases;
  8. Failure to sign informed consent due to cognitive impairment or other conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Acute pancreatitis
Patients with a complete diagnosis of MSAP and SAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who developed glucose metabolic disorders (pre-diabetes and diabetes mellitus)
Time Frame: From the AP treatment to 5 years after the end of treatment
The diagnosis of glucose metabolic disorders should be made applying the criteria of the American Diabetes Association.
From the AP treatment to 5 years after the end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Changzheng Hospital

Collaborators

Changhai Hospital

Investigators

  • Study Director: tuo Li, Prof., Shanghai Changzheng Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

August 29, 2024

First Submitted That Met QC Criteria

September 6, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 19, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMU-3cDM-1B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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