- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06590233
Hyperglycemia and Acute Pancreatitis
September 13, 2024 updated by: Tuo Li, MD, Shanghai Changzheng Hospital
The Risk Factors and Predictors of Hyperglycemia Secondary to Acute Pancreatitis
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:
- What are the clinical characteristics of PPDM-A?
- What are the related factors for PPDM-A?
All patients with acute pancreatitis have been given standardized treatment for the condition.
The researchers will compare the PPDM-A group with the non-PPDM-A group to find the risk factors for PPDM-A.
Study Overview
Status
Completed
Conditions
Detailed Description
Investigators retrospectively collected data from patients with acute pancreatitis (AP) in participating centers between January 2013 and June 2024.
Study Type
Observational
Enrollment (Actual)
4500
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
We collected data from patients with acute pancreatitis (AP) in participating centers between January 2013 and June 2024.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Acute pancreatitis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants who have developed PPDM-A
Time Frame: From the AP treatment to 5 years after the end of treatment
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2013
Primary Completion (Actual)
August 1, 2024
Study Completion (Actual)
August 1, 2024
Study Registration Dates
First Submitted
August 29, 2024
First Submitted That Met QC Criteria
September 5, 2024
First Posted (Estimated)
September 10, 2024
Study Record Updates
Last Update Posted (Estimated)
September 19, 2024
Last Update Submitted That Met QC Criteria
September 13, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NMU-3cDM-1A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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