Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-27 @ 11:34 PM
Study NCT ID:
NCT06573060
Status:
UNKNOWN
Last Update Posted:
2024-08-27
First Post:
2024-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycemic Variability, Gut Microbiota, and Prognosis in T2DM With ACS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095583', 'term': 'Continuous Glucose Monitoring'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Faeces and blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-24', 'studyFirstSubmitDate': '2024-08-01', 'studyFirstSubmitQcDate': '2024-08-24', 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major adverse cardiovascular events', 'timeFrame': '2023.7-2025.10', 'description': 'Composite Major Adverse Cardiovascular Events (MACE)'}], 'secondaryOutcomes': [{'measure': 'cardiovascular mortality', 'timeFrame': '2023.7-2025.10', 'description': 'Deaths due to heart and/or vascular disease. According to the World Health Organisation (WHO) classification, cardiovascular diseases include a wide range of diseases such as coronary heart disease, myocardial infarction, stroke and hypertension.'}, {'measure': 'ACS Recurrence', 'timeFrame': '2023.7-2025.10', 'description': 'Refers to the recurrence of a new ACS event after an episode of ACS. Depending on the signs and symptoms, patients can be classified as having STEMI, NSTEMI, or unstable angina.'}, {'measure': 'Angina requiring revascularisation', 'timeFrame': '2023.7-2025.10', 'description': 'Presence of indications for coronary revascularisation'}, {'measure': 'Acute decompensated heart failure requiring hospitalisation', 'timeFrame': '2023.7-2025.10', 'description': "Clinical syndrome caused by acute imbalance of oxygen supply and demand due to impaired cardiac function, manifested by dyspnoea, pulmonary oedema and peripheral oedema. The patient's condition is severe enough to require hospitalisation."}, {'measure': 'Strokes requiring hospitalisation', 'timeFrame': '2023.7-2025.10', 'description': "An acute disease with sudden defects in brain function, such as sudden motor, sensory, speech, and vision disorders. The patient's condition is serious enough to require hospitalisation for treatment and observation."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gut microbiome', 'Type 2 Diabetes mellitus', 'coronary heart disease', 'glycemic variability'], 'conditions': ['Type 2 Diabetes Mellitus', 'Coronary Heart Disease']}, 'referencesModule': {'references': [{'pmid': '15939812', 'type': 'BACKGROUND', 'citation': 'Kosiborod M, Rathore SS, Inzucchi SE, Masoudi FA, Wang Y, Havranek EP, Krumholz HM. Admission glucose and mortality in elderly patients hospitalized with acute myocardial infarction: implications for patients with and without recognized diabetes. Circulation. 2005 Jun 14;111(23):3078-86. doi: 10.1161/CIRCULATIONAHA.104.517839. Epub 2005 Jun 6.'}, {'pmid': '20609967', 'type': 'BACKGROUND', 'citation': 'Emerging Risk Factors Collaboration; Sarwar N, Gao P, Seshasai SR, Gobin R, Kaptoge S, Di Angelantonio E, Ingelsson E, Lawlor DA, Selvin E, Stampfer M, Stehouwer CD, Lewington S, Pennells L, Thompson A, Sattar N, White IR, Ray KK, Danesh J. Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies. Lancet. 2010 Jun 26;375(9733):2215-22. doi: 10.1016/S0140-6736(10)60484-9.'}]}, 'descriptionModule': {'briefSummary': 'Patients with type 2 diabetes mellitus (T2DM) diagnosed with acute coronary syndrome (ACS) by coronary angiography in the Second Affiliated Hospital of Nanchang University were consecutively included in a prospective cohort study. During the acute phase of ACS, blood glucose was monitored using a continuous glucose monitoring system (CGM) for 14 days, and for patients who had been hospitalised for less than 14 days, they continued to wear the CGM for monitoring blood glucose until 14 days after discharge. During this period, stool and serum samples were analysed for multi-omics (16s rRNA sequencing and metabolomics). Subsequently, a follow-up period of at least 1 year was performed to observe the patients for the occurrence of adverse cardiovascular events (MACE) during the follow-up period and to assess the impact of glycaemic variability and gut flora and its metabolites on the prognosis of patients with T2DM combined with ACS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '120', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nClinical diagnosis of Type 2 Diabetes Mellitus (T2DM).\n\nClinical diagnosis of Acute Coronary Syndrome (ACS).\n\nExclusion Criteria:\n\nHistory of hemodialysis.\n\nRecent antibiotic use within the past two weeks.\n\nActive malignant tumors.\n\nPregnancy and breastfeeding.\n\nInability to wear sensors due to severe skin conditions.\n\nCoagulation disorders, anemia, or abnormal hematocrit levels.\n\nRequirement for MRI during the sensor-wearing period.\n\nInability to follow study instructions or deemed unsuitable for the trial by the treating clinician/nurse.\n\nInability to understand informed consent or communicate with researchers due to cognitive decline or mental illness.'}, 'identificationModule': {'nctId': 'NCT06573060', 'briefTitle': 'Glycemic Variability, Gut Microbiota, and Prognosis in T2DM With ACS', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital of Nanchang University'}, 'officialTitle': 'Impact of Glycemic Variability and Gut Microbiota and Metabolites on the Prognosis of Patients With Type 2 Diabetes Mellitus Combined With Acute Coronary Syndrome', 'orgStudyIdInfo': {'id': 'DMACS20240719'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ACS+T2DM', 'description': 'Patients with Type 2 Diabetes Mellitus (T2DM) diagnosed with Acute Coronary Syndrome (ACS) through coronary angiography.', 'interventionNames': ['Device: Continuous glucose monitoring']}], 'interventions': [{'name': 'Continuous glucose monitoring', 'type': 'DEVICE', 'description': 'Subjects with T2DM and acute coronary syndrome (n=120) were fitted with continuous glucose monitors (CGM) to closely monitor their blood glucose levels continuously for 14 days.', 'armGroupLabels': ['ACS+T2DM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '330000', 'city': 'Nanchang', 'state': 'Jiangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yunfeng Shen', 'role': 'CONTACT', 'email': '1023744018@qq.com', 'phone': '18970819455'}, {'name': 'Xiaojuan Jiao', 'role': 'CONTACT', 'email': 'syf92@live.com', 'phone': '18970819455'}], 'facility': 'The Second Affiliated Hospital Of Nanchang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}], 'centralContacts': [{'name': 'YunFeng Shen, PhD degree', 'role': 'CONTACT', 'email': 'syf92@live.com', 'phone': '+8618970819455'}], 'overallOfficials': [{'name': 'Xiaojuan Jiao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital of Nanchang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Privacy and confidentiality issues: Participants' data may contain sensitive personal information. Sharing this data could lead to privacy breaches, violating data protection regulations (such as GDPR)."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital of Nanchang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}