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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06590935

Enrollment

120

Registered

2024-09-19

Start date

2024-10-08

Completion date

2026-09-30

Last updated

2025-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pancreatitis (AP), Diabetes Mellitus

Keywords

Acute pancreatitis, Diabetes mellitus, PPDM-A, Risk factor

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 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.

Detailed description

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants Who developed glucose metabolic disorders (pre-diabetes and diabetes mellitus)	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.

Countries

China

Outcome results