Clinical trial NCT06590233: Hyperglycemia and Acute Pancreatitis
Official title: The Risk Factors and Predictors of Hyperglycemia Secondary to Acute Pancreatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Pancreatitis (AP)
Diabetes Mellitus
Keywords: Acute pancreatitis
Diabetes mellitus
PPDM-A
Risk factor
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
Collaborators: name: Changhai Hospital
First posted: 2024-09-19
Enrollment: 4500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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

Detailed description: Investigators retrospectively collected data from patients with acute pancreatitis (AP) in participating centers between January 2013 and June 2024.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Number of participants who have developed PPDM-A
timeFrame: From the AP treatment to 5 years after the end of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.