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

NCT06590935 | Active Not Recruiting DMC

• 1 other identifier: NMU-3cDM-1B
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Pancreatitis (AP); Diabetes Mellitus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who developed glucose metabolic disorders (pre-diabetes and diabetes mellitus)

  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

Study Arms (1)

Acute pancreatitis

Patients with a complete diagnosis of MSAP and SAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead
• Changhai Hospital: collaborator

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 20003, China

Location

Related Publications (8)

• Bharmal SH, Cho J, Ko J, Petrov MS. Glucose variability during the early course of acute pancreatitis predicts two-year probability of new-onset diabetes: A prospective longitudinal cohort study. United European Gastroenterol J. 2022 Mar;10(2):179-189. doi: 10.1002/ueg2.12190. Epub 2022 Feb 20.

  PMID: 35188346 BACKGROUND

• Bharmal SH, Cho J, Alarcon Ramos GC, Ko J, Stuart CE, Modesto AE, Singh RG, Petrov MS. Trajectories of glycaemia following acute pancreatitis: a prospective longitudinal cohort study with 24 months follow-up. J Gastroenterol. 2020 Aug;55(8):775-788. doi: 10.1007/s00535-020-01682-y. Epub 2020 Jun 3.

  PMID: 32494905 BACKGROUND

• Zhong S, Du Q, Liu N, Chen Y, Yang T, Qin S, Jiang Y, Huang X. Developing a CT-based radiomics nomogram for predicting post-acute pancreatitis diabetes mellitus incidence. Br J Radiol. 2023 Dec;96(1152):20230382. doi: 10.1259/bjr.20230382. Epub 2023 Oct 24.

  PMID: 37750855 BACKGROUND

• Lv Y, Zhang J, Yang T, Sun J, Hou J, Chen Z, Yu X, Yuan X, Lu X, Xie T, Yu T, Su X, Liu G, Zhang C, Li L. Non-Alcoholic Fatty Liver Disease (NAFLD) Is an Independent Risk Factor for Developing New-Onset Diabetes After Acute Pancreatitis: A Multicenter Retrospective Cohort Study in Chinese Population. Front Endocrinol (Lausanne). 2022 May 25;13:903731. doi: 10.3389/fendo.2022.903731. eCollection 2022.

  PMID: 35692404 BACKGROUND

• Yu BJ, Li NS, He WH, He C, Wan JH, Zhu Y, Lu NH. Pancreatic necrosis and severity are independent risk factors for pancreatic endocrine insufficiency after acute pancreatitis: A long-term follow-up study. World J Gastroenterol. 2020 Jun 21;26(23):3260-3270. doi: 10.3748/wjg.v26.i23.3260.

  PMID: 32684740 BACKGROUND

• Zhi M, Zhu X, Lugea A, Waldron RT, Pandol SJ, Li L. Incidence of New Onset Diabetes Mellitus Secondary to Acute Pancreatitis: A Systematic Review and Meta-Analysis. Front Physiol. 2019 May 31;10:637. doi: 10.3389/fphys.2019.00637. eCollection 2019.

  PMID: 31231233 BACKGROUND

• Das SL, Singh PP, Phillips AR, Murphy R, Windsor JA, Petrov MS. Newly diagnosed diabetes mellitus after acute pancreatitis: a systematic review and meta-analysis. Gut. 2014 May;63(5):818-31. doi: 10.1136/gutjnl-2013-305062. Epub 2013 Aug 8.

  PMID: 23929695 BACKGROUND

• Shen HN, Yang CC, Chang YH, Lu CL, Li CY. Risk of Diabetes Mellitus after First-Attack Acute Pancreatitis: A National Population-Based Study. Am J Gastroenterol. 2015 Dec;110(12):1698-706. doi: 10.1038/ajg.2015.356. Epub 2015 Nov 3.

  PMID: 26526084 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood samples will be collected at every visit

MeSH Terms

Conditions

Pancreatitis; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Tuo Li, Prof.

  Shanghai Changzheng Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 52 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: September 19, 2024
• Study Start: October 8, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)