Status:
ACTIVE_NOT_RECRUITING
Endocrine and Exocrine Secretory Function Alterations After Moderately Severe and Severe Acute Pancreatitis
Lead Sponsor:
Shanghai Changzheng Hospital
Collaborating Sponsors:
Changhai Hospital
Conditions:
Acute Pancreatitis (AP)
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Brief Summary
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 dis...
Detailed Description
Investigators will prospectively collect data from patients with moderately severe (MSAP) and severe acute pancreatitis (SAP) in participant centers.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 8 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06590935
Start Date
October 8 2024
End Date
September 1 2026
Last Update
February 21 2025
Active Locations (1)
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1
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China, 20003