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

N

Naval Military Medical University (Second Military Medical University)

Status

Active, not recruiting

Conditions

Diabetes Mellitus
Acute Pancreatitis (AP)

Study type

Observational

Funder types

Other

Identifiers

NCT06590935
NMU-3cDM-1B

Details and patient eligibility

About

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.

Full description

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

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

120 participants in 1 patient group

Acute pancreatitis
Description:
Patients with a complete diagnosis of MSAP and SAP

Trial contacts and locations

1

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Central trial contact

Tuo Dr. Li, Vice Professor

Data sourced from clinicaltrials.gov

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