Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-01-08 @ 10:49 AM
Study NCT ID:
NCT06590233
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2024-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hyperglycemia and Acute Pancreatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-13', 'studyFirstSubmitDate': '2024-08-29', 'studyFirstSubmitQcDate': '2024-09-05', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who have developed PPDM-A', 'timeFrame': 'From the AP treatment to 5 years after the end of treatment', 'description': 'PPDM-A was defined as diabetes after AP in the absence of a history of preexisting diabetes before the AP episode.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute pancreatitis', 'Diabetes mellitus', 'PPDM-A', 'Risk factor'], 'conditions': ['Acute Pancreatitis (AP)', 'Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '35188346', 'type': 'BACKGROUND', '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.'}, {'pmid': '32494905', 'type': 'BACKGROUND', '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.'}, {'pmid': '37750855', 'type': 'BACKGROUND', '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.'}, {'pmid': '35692404', 'type': 'BACKGROUND', '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.'}, {'pmid': '32684740', 'type': 'BACKGROUND', '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.'}, {'pmid': '31231233', 'type': 'BACKGROUND', '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.'}, {'pmid': '23929695', 'type': 'BACKGROUND', '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.'}, {'pmid': '26526084', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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:\n\n1. What are the clinical characteristics of PPDM-A?\n2. What are the related factors for PPDM-A?\n\nAll patients with acute pancreatitis have been given standardized treatment for the condition.\n\nThe researchers will compare the PPDM-A group with the non-PPDM-A group to find the risk factors for PPDM-A.', 'detailedDescription': 'Investigators retrospectively collected data from patients with acute pancreatitis (AP) in participating centers between January 2013 and June 2024.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We collected data from patients with acute pancreatitis (AP) in participating centers between January 2013 and June 2024.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with pancreatitis attending participating centers since January 2013 (patients with clinically reported AP (ICD-10:K85 or related diagnosis));\n2. Age between 18 and 80 years;\n3. Patients have undergone glucose metabolic tests at least 1 month after discharge from hospital.\n\nExclusion Criteria:\n\n1. Patients with a history of diabetes mellitus prior to the AP attack;\n2. Patients who underwent pancreatic surgery;\n3. Patients with hereditary pancreatitis and autoimmune pancreatitis;\n4. Patients with missing data regarding age or gender.'}, 'identificationModule': {'nctId': 'NCT06590233', 'briefTitle': 'Hyperglycemia and Acute Pancreatitis', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Changzheng Hospital'}, 'officialTitle': 'The Risk Factors and Predictors of Hyperglycemia Secondary to Acute Pancreatitis', 'orgStudyIdInfo': {'id': 'NMU-3cDM-1A'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute pancreatitis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Changzheng Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Changhai Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Director', 'investigatorFullName': 'Tuo Li, MD', 'investigatorAffiliation': 'Shanghai Changzheng Hospital'}}}}