Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-27 @ 2:53 PM
Study NCT ID:
NCT06277466
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Mutations in T2DM Susceptibility Genes on the Expression of Susceptibility Genes in Patients With T2DM and Controls
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D020022', 'term': 'Genetic Predisposition to 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': 'D004198', 'term': 'Disease Susceptibility'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007004', 'term': 'Hypoglycemic Agents'}], 'ancestors': [{'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2028-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-25', 'studyFirstSubmitDate': '2024-02-05', 'studyFirstSubmitQcDate': '2024-02-18', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of T2DM susceptibility gene expression in newly diagnosed T2DM patients', 'timeFrame': '1 month after fresh sample collection', 'description': 'To detect the expression levels of susceptible genes in the plasma and the pancreatic tissues of newly diagnosed T2DM patients and compared with those in healthy subjects.'}, {'measure': 'Detection of T2DM susceptibility gene expression in controls', 'timeFrame': '1 month after fresh sample collection', 'description': 'To detect the expression levels of susceptible genes in the plasma and the pancreatic tissues of controls and compared with those in newly diagnosed T2DM patients.'}, {'measure': 'Correlation between T2DM susceptibility gene expression and clinicopathological features', 'timeFrame': '6 months after obtaining the clinicopathological results', 'description': 'Incidence of clinical pancreatic diseases under expression differences in T2DM susceptibility genes'}], 'secondaryOutcomes': [{'measure': 'Baseline BMI of newly diagnosed with T2DM patients with different genotypes', 'timeFrame': '1 month of completion for individual screening', 'description': 'Baseline BMI of newly diagnosed with T2DM patients'}, {'measure': 'Baseline waist hip ratio (WHR) of newly diagnosed with T2DM patients with different genotypes', 'timeFrame': '1 month of completion for individual screening', 'description': 'Baseline WHR of newly diagnosed with T2DM patients'}, {'measure': 'Baseline fasting plasma glucose (FPG) of newly diagnosed with T2DM patients with different genotypes', 'timeFrame': '1 month of completion for individual screening', 'description': 'Baseline FPG of newly diagnosed with T2DM patients'}, {'measure': 'Baseline HbA1c of newly diagnosed with T2DM patients with different genotypes', 'timeFrame': '1 month of completion for individual screening', 'description': 'Baseline HbA1c of newly diagnosed with T2DM patients'}, {'measure': 'Baseline TC of newly diagnosed with T2DM patients with different genotypes', 'timeFrame': '1 month of completion for individual screening', 'description': 'Baseline TC of newly diagnosed with T2DM patients'}, {'measure': 'Baseline TG of newly diagnosed with T2DM patients with different genotypes', 'timeFrame': '1 month of completion for individual screening', 'description': 'Baseline TG of newly diagnosed with T2DM patients'}, {'measure': 'Baseline HDL-C of newly diagnosed with T2DM patients with different genotypes', 'timeFrame': '1 month of completion for individual screening', 'description': 'Baseline HDL-C of newly diagnosed with T2DM patients'}, {'measure': 'Baseline LDL-C of newly diagnosed with T2DM patients with different genotypes', 'timeFrame': '1 month of completion for individual screening', 'description': 'Baseline LDL-C of newly diagnosed with T2DM patients'}, {'measure': 'Baseline BMI of controls with different genotypes', 'timeFrame': '1 month of completion for individual screening', 'description': 'Baseline BMI of controls'}, {'measure': 'Baseline WHR of controls with different genotypes', 'timeFrame': '1 month of completion for individual screening', 'description': 'Baseline WHR of controls'}, {'measure': 'Baseline FPG of controls with different genotypes', 'timeFrame': '1 month of completion for individual screening', 'description': 'Baseline FPG of controls'}, {'measure': 'Baseline HbA1c of controls with different genotypes', 'timeFrame': '1 month of completion for individual screening', 'description': 'Baseline HbA1c of controls'}, {'measure': 'Baseline TC of controls with different genotypes', 'timeFrame': '1 month of completion for individual screening', 'description': 'Baseline TC of controls'}, {'measure': 'Baseline TG of controls with different genotypes', 'timeFrame': '1 month of completion for individual screening', 'description': 'Baseline TG of controls'}, {'measure': 'Baseline HDL-C of controls with different genotypes', 'timeFrame': '1 month of completion for individual screening', 'description': 'Baseline HDL-C of controls'}, {'measure': 'Baseline LDL-C of controls with different genotypes', 'timeFrame': '1 month of completion for individual screening', 'description': 'Baseline LDL-C of controls'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['T2DM', 'gene polymorphism', 'susceptibility gene', 'genetic mutations'], 'conditions': ['Type 2 Diabetes Mellitus', 'Gene Polymorphisms', 'Genetic Mutations', 'Susceptibility, Genetic']}, 'descriptionModule': {'briefSummary': 'In this study, investigators wanted to determine the effect of T2DM susceptibility gene mutations on self-expression.\n\nParticipants (T2DM patients and controls) were recruited to identify genotypes and detect the levels of T2DM susceptibility genes expression in the fresh peripheral plasma. The normal pancreatic tissues or adjacent tissues of pancreatic cancer were also collected to identify the expression differences of T2DM susceptibility genes under different genotypes.', 'detailedDescription': 'The primary objective of this study was to investigate the changes of the expression of T2DM susceptible genes (NOS1AP, KCNQ1, TCF7L2, WSF1, GLP-1R, etc.) in participants (newly diagnosed T2DM patients and controls) after gene mutation.\n\nSecondly, the expression differences of T2DM susceptible genes in T2DM patients with different genotypes were compared, and the relationship between the expression differences and clinicopathological characteristics of T2DM patients was analyzed.\n\nParticipants (newly diagnosed T2DM patients and healthy subjects) were screened from the department of endocrinology and health management center, whose fresh peripheral blood were collected. The normal pancreatic tissues or adjacent tissues of pancreatic cancer were collected in the department of general surgery. The DNA genome was extracted for genotyping, and then the expression levels of T2DM related susceptibility genes under different genotypes were detected by ELISA kits, PCR, WB,HE staining, IHC staining, ect.\n\nThe basic information of T2DM patients was collected, including demographic characteristics, physiological and biochemical data.Then investigators further compared the differences in the expression of susceptible genes between newly diagnosed T2DM patients and controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. no drug therapy; 25 to 70 years old; Hemoglobin A1c (HbA1c) 7%-12%; BMI 20-35 kg/m2; Stable body weight (≤10% change within 3 months)（For newly diagnosed patients with T2DM）.\n2. 25 to 60 years old; BMI 19-26 kg/m2; in good health, with no abnormalities of motor system, digestive system, respiratory system, urogenital system, blood system, circulatory system, nervous/mental system, endocrine system, etc（For healthy subjects）.\n3. 20-80 years old; surgical resection of part or all of the pancreas; pancreatic lesions confirmed by enhanced CT or magnetic resonance (MR) examination or confirmed by intraoperative and postoperative pathology（For the patients in general surgical）.\n\nExclusion Criteria:\n\n1. had taken antidiabetic drugs;\n2. had a history of pancreatic surgery;\n3. Complicated with severe organ lesions;\n4. Long-term use of drugs that affect pancreatic function.'}, 'identificationModule': {'nctId': 'NCT06277466', 'briefTitle': 'Effect of Mutations in T2DM Susceptibility Genes on the Expression of Susceptibility Genes in Patients With T2DM and Controls', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Hospital of Xuzhou Medical University'}, 'officialTitle': 'Department of Pharmacy, the Affiliated Hospital of Xuzhou Medical University', 'orgStudyIdInfo': {'id': 'XYFY2023-KL478-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Comparison of T2DM susceptibility gene expression between newly diagnosed T2DM patients and controls', 'description': 'To determine the effect of gene mutations on the susceptibility of T2DM by comparing the expression levels of T2DM susceptibility genes in newly diagnosed T2DM patients and controls.', 'interventionNames': ['Drug: Fresh normal pancreatic tissues or adjacent tissues of pancreatic cancer were collected from controls and T2DM patients without hypoglycemic drugs', 'Drug: Fresh blood samples were collected from healthy subjects and T2DM patients without hypoglycemic drugs']}], 'interventions': [{'name': 'Fresh normal pancreatic tissues or adjacent tissues of pancreatic cancer were collected from controls and T2DM patients without hypoglycemic drugs', 'type': 'DRUG', 'description': 'Compared with newly diagnosed T2DM patients, healthy subjects in the control group had normal levels of blood glucose, lipids, glycated hemoglobin levels, etc. Fresh normal pancreatic tissues or adjacent tissues of pancreatic cancer were collected before taking antidiabetic drugs in both groups.', 'armGroupLabels': ['Comparison of T2DM susceptibility gene expression between newly diagnosed T2DM patients and controls']}, {'name': 'Fresh blood samples were collected from healthy subjects and T2DM patients without hypoglycemic drugs', 'type': 'DRUG', 'description': 'The newly diagnosed T2DM group should not have taken antidiabetic drugs and meet the diagnosis of T2DM. Fresh blood samples were collected before medication for detection.\n\nIn the control group (healthy subjects), the indicators of physical examination were within the normal range and no hypoglycemic drugs were taken. Similarly, fresh blood samples should be taken for testing.', 'armGroupLabels': ['Comparison of T2DM susceptibility gene expression between newly diagnosed T2DM patients and controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '221006', 'city': 'Xuzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongwei Ling, MD', 'role': 'CONTACT', 'email': 'linghongwei@medmail.com.cn', 'phone': '18052268607'}, {'name': 'Renguo Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yuhan Huang, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'China, Jiangsu, Department of Endocrinology', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}], 'centralContacts': [{'name': 'Tao Wang, Ph.D', 'role': 'CONTACT', 'email': 'misswt2011@126.com', 'phone': '13815344640'}, {'name': 'Xiaoxing Yin, Ph.D', 'role': 'CONTACT', 'email': 'yinxx@xzmc.edu.cn', 'phone': '13605218523'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Hospital of Xuzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}