Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-28 @ 1:20 AM
Study NCT ID:
NCT04579406
Status:
UNKNOWN
Last Update Posted:
2023-04-12
First Post:
2020-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Adverse Cardiovascular Event in Type-2 Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D009410', 'term': 'Nerve Degeneration'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-10', 'studyFirstSubmitDate': '2020-10-01', 'studyFirstSubmitQcDate': '2020-10-01', 'lastUpdatePostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'adverse cardiovascular events', 'timeFrame': 'Perioperative period', 'description': 'All the pre-, intra- and post-operative adverse cardiovascular events in the patients will be taken into account.'}], 'secondaryOutcomes': [{'measure': 'NPY, CGRP, SP and TRPV1', 'timeFrame': 'Perioperative period', 'description': 'The difference in the serum levels of NPY, CGRP, SP and TRPV1'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes mellitus', 'adverse cardiovascular events', 'nerve degeneration', 'peripheral sensory nerves'], 'conditions': ['Type 2 Diabetes', 'Neuropathy']}, 'descriptionModule': {'briefSummary': 'The study was designed to investigate the correlation between perioperative adverse cardiovascular events and the degeneration of sensory nerves in patient diagnosed with type 2 diabetes mellitus, undergoing elective non-cardiac surgery.', 'detailedDescription': 'The study was designed to investigate the correlation between perioperative adverse cardiovascular events and the degeneration of sensory nerves in patient diagnosed with type 2 diabetes mellitus, undergoing elective non-cardiac surgery. Diabetes mellitus and peripheral sensory nerve degeneration will be diagnosed via clinical evaluation. Serum levels of constituent neuropeptides, including neuropeptide Y (NPY), calcitonin and substance P (SP) and calcitonin gene related peptide (CGRP), and transient receptor potential vanilloid 1 (TRPV1), a molecular nociceptor in peripheral sensory nerves will be quantitatively evaluated. The clinical and the biochemical consequence will be compared between the cohorts of diabetic and non-diabetic patients. The differences and the correlations will be analyzed. The results of the study may reveal whether or not the perioperative adverse cardiovascular events in diabetic patients are correlated with degeneration of peripheral sensory nerves and the alterations in the neuropeptides and TRPV1 are potentially applicable for evaluation of the risk of cardiovascular events in perioperative period in diabetic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Type 2 diabetic patients with and without peripheral sensory neuropathy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The main discharge diagnosis is T2DM；\n* Age \\> 18 years old;\n* No acute complications of diabetes\n\nExclusion Criteria:\n\n* T1DM patients;\n* EGFR \\< 60 ml/min/1.73 m or proteinuria (or both);\n* Patients with history of acute cardiovascular events;\n* Familial hypercholesterolemia or other hereditary lipid metabolism diseases;\n* anti-HIV patients;\n* Patients with serious mental health problems;\n* Patients receiving drugs that can lead to dyslipidemia, such as antipsychotics, corticosteroids, or immunosuppressants;\n* Patients with systemic inflammatory diseases, such as systemic lupus erythematosus;\n* Patient are quitting smoking and severe obesity (BMI\\>40)'}, 'identificationModule': {'nctId': 'NCT04579406', 'acronym': 'DMPACE', 'briefTitle': 'Perioperative Adverse Cardiovascular Event in Type-2 Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Second Hospital of Shanxi Medical University'}, 'officialTitle': 'Association of Changes in NPY, CGRP, SP and TRPV1 With Perioperative Adverse Cardiovascular Event in Type-2 Diabetic Patients', 'orgStudyIdInfo': {'id': 'ScondShanxiMU-1646'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'non-diabetic group', 'description': 'The non-diabetic patients undergoing non-cardiac surgery.', 'interventionNames': ['Procedure: non-cardiac surgery']}, {'label': 'Diabetic group', 'description': 'The diabetic patients without peripheral neuropathy undergoing non-cardiac surgery.', 'interventionNames': ['Procedure: non-cardiac surgery']}, {'label': 'Diabetic neuropathic group', 'description': 'The diabetic patients with peripheral neuropathy undergoing non-cardiac surgery.', 'interventionNames': ['Procedure: non-cardiac surgery']}], 'interventions': [{'name': 'non-cardiac surgery', 'type': 'PROCEDURE', 'description': 'All the patients are undergoing non-cardiac surgery.', 'armGroupLabels': ['Diabetic group', 'Diabetic neuropathic group', 'non-diabetic group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '030001', 'city': 'Taiyuan', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zheng Guo, MB，PhD', 'role': 'CONTACT', 'email': 'guozheng713@yahoo.com', 'phone': '+863513365790'}, {'name': 'Weijun Liang, MSc', 'role': 'CONTACT', 'email': 'weijun_liang@126.com', 'phone': '+863513365790'}, {'name': 'Zheng Guo, MB, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zheng Guo', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}], 'centralContacts': [{'name': 'Zheng Guo, M.B., Ph.D.', 'role': 'CONTACT', 'email': 'guozheng713@yahoo.com', 'phone': '+863513365790'}], 'overallOfficials': [{'name': 'Zheng Guo, M.B., Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Second Hospital of Shanxi Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Yes, if possible.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Hospital of Shanxi Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and chairman of the Department of Anesthesiology', 'investigatorFullName': 'Zheng Guo', 'investigatorAffiliation': 'Second Hospital of Shanxi Medical University'}}}}