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Active, Not Recruiting

NCT Number: NCT06590935

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Acute Pancreatitis (AP) Diabetes Mellitus Digestive System Diseases Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pancreatic Diseases Pancreatitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 20003, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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;
  • Patients have any evidence of type 1 diabetes-related autoimmunity;
  • Patients have any risk for secondary diabetes due to exposure to medications or other endocrine diseases;
  • Combined with pancreas-related trauma or a history of pancreatic surgery;
  • Patients undergo pancreatic surgery during treatment;
  • Pregnancy or breastfeeding;
  • Patients suffer from severe cardiac, hepatic or renal insufficiency or malignant diseases;
  • Failure to sign informed consent due to cognitive impairment or other conditions

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Shanghai Changzheng Hospital

Other

Collaborators

  • Changhai Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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