NCT06590233

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.What are the clinical characteristics of PPDM-A?
  2. 2.What are the related factors for PPDM-A?

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
11.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

11.6 years

First QC Date

August 29, 2024

Last Update Submit

September 13, 2024

Conditions

Keywords

Acute pancreatitisDiabetes mellitusPPDM-ARisk factor

Outcome Measures

Primary Outcomes (1)

  • Number of participants who have developed PPDM-A

    PPDM-A was defined as diabetes after AP in the absence of a history of preexisting diabetes before the AP episode.

    From the AP treatment to 5 years after the end of treatment

Study Arms (1)

Acute pancreatitis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We collected data from patients with acute pancreatitis (AP) in participating centers between January 2013 and June 2024.

You may qualify if:

  • Patients with pancreatitis attending participating centers since January 2013 (patients with clinically reported AP (ICD-10:K85 or related diagnosis));
  • Age between 18 and 80 years;
  • Patients have undergone glucose metabolic tests at least 1 month after discharge from hospital.

You may not qualify if:

  • Patients with a history of diabetes mellitus prior to the AP attack;
  • Patients who underwent pancreatic surgery;
  • Patients with hereditary pancreatitis and autoimmune pancreatitis;
  • Patients with missing data regarding age or gender.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 35188346BACKGROUND
  • 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: 32494905BACKGROUND
  • 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: 37750855BACKGROUND
  • 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: 35692404BACKGROUND
  • 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: 32684740BACKGROUND
  • 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: 31231233BACKGROUND
  • 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: 23929695BACKGROUND
  • 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: 26526084BACKGROUND

MeSH Terms

Conditions

PancreatitisDiabetes Mellitus

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
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

January 1, 2013

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share