Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-28 @ 8:27 PM
Study NCT ID:
NCT06164535
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-11
First Post:
2023-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of DPPIs on Cognitive Function of Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'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': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}, {'id': 'D054873', 'term': 'Dipeptidyl-Peptidase IV Inhibitors'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D011480', 'term': 'Protease Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D007004', 'term': 'Hypoglycemic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'all patient information will be anonymized giving only corresponding numbers, which will be revealed by the PI after assessment.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 105}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-07', 'studyFirstSubmitDate': '2023-11-30', 'studyFirstSubmitQcDate': '2023-12-07', 'lastUpdatePostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Inflammatory mediators; TNF-α', 'timeFrame': 'Before and post 6 month of treatment', 'description': 'ELISA kits'}, {'measure': 'MMSE score', 'timeFrame': 'Before and post 6 month of treatment', 'description': 'Validated questionnaire assessing the Estimation of Mini Mental State The MMSE has a maximum score of 30 points. The scores are generally grouped as follows: 25-30 points: normal cognition 21-24 points: mild dementia 10-20 points: moderate dementia Examination (MMSE) score'}, {'measure': 'PHQ-9', 'timeFrame': 'Before and post 6 month of treatment', 'description': 'Validated questionnaire assessing patient mental health and depression PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression.;'}, {'measure': 'serum amyloid-β', 'timeFrame': 'Before and post 6 month of treatment'}], 'secondaryOutcomes': [{'measure': 'Serum Insulin', 'timeFrame': 'Before and post 6 month of treatment', 'description': 'ElISA kits'}, {'measure': 'Serum fasting and 2-he post prandial glucose', 'timeFrame': 'Before and post 6 month of treatment'}, {'measure': 'HOMA-IR', 'timeFrame': 'Before and post 6 month of treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cognitive', 'DPP-4 inhibitors', 'Diabetes', 'Depression'], 'conditions': ['Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'This is a single-center, randomized controlled clinical trial with a parallel-group design conducted at Minia University hospital.', 'detailedDescription': 'All patients admitted to Diabetes clinics of Minia University Hospital, will be screened for the eligibility criteria.\n\ndiabetic patients (aged above 50 years) with uncontrolled diabetes on oral hypoglycemic drugs. 105 patients will be enrolled and randomized into three groups.\n\nGroup I=35 T2DM patients given DPP4Is Group II=35 T2DM patients given DPP4Is and metformin. Group III=35 patients will be given placebo (only adjust their drugs to control blood glucose level)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nType-2 diabetic adult subjects (above 50 years old) who had uncontrolled (A1c=8-9 %) blood glucose levels with an oral hypoglycemic drug at the screening visit were eligible to participate.\n\nExclusion Criteria:\n\nThose with type1 diabetes or ketoacidosis, end organ failure as chronic renal failure (estimated serum creatinine level ≥ 1.5mg/dl in male and ≥ 1.4mg/dl in female), liver cell failure (elevated alanine transaminase (ALT) and aspartate transaminase (AST) ≥ 2 folds), and heart failure, previous history of pancreatitis, and pregnant or lactating females were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT06164535', 'briefTitle': 'The Effects of DPPIs on Cognitive Function of Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'The Effects of Some Antihyperglycemic Drugs on Cognitive Function and Risk of Depression of Diabetic Patients', 'orgStudyIdInfo': {'id': 'BeniSuefU2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': '35 patients will be given placebo (only adjust their drugs to control blood glucose level)', 'interventionNames': ['Drug: Control group']}, {'type': 'EXPERIMENTAL', 'label': 'DPPI Group', 'description': '35 T2DM patients will be given DPP4Is once or twice daily', 'interventionNames': ['Drug: DPP-4 inhibitor group']}, {'type': 'EXPERIMENTAL', 'label': 'DPPI + metformin group', 'description': '35 T2DM patients will be given DPP4Is + metformin once or twice daily', 'interventionNames': ['Drug: DPP-4 inhibitor + metformin group']}], 'interventions': [{'name': 'Control group', 'type': 'DRUG', 'description': '35 T2DM patients will be given placebo (only adjust their drugs to control blood glucose level)', 'armGroupLabels': ['Control Group']}, {'name': 'DPP-4 inhibitor group', 'type': 'DRUG', 'description': '35 T2DM patients will be given DPP-4 I once or twice daily', 'armGroupLabels': ['DPPI Group']}, {'name': 'DPP-4 inhibitor + metformin group', 'type': 'DRUG', 'description': '35 T2DM patients will be given DPP-4 I + metformin once or twice daily', 'armGroupLabels': ['DPPI + metformin group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '82511', 'city': 'Minya', 'country': 'Egypt', 'contacts': [{'name': 'Asmaa Elsayed', 'role': 'CONTACT', 'email': 'asmaa.abdelfattah@pharm.sohag.edu.eg', 'phone': '+201095727201'}, {'name': 'Engy Wahsh, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Shireen Riad, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Asmaa Mohamed, Ph.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Minia University hospital', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}], 'centralContacts': [{'name': 'Asmaa Elsayed', 'role': 'CONTACT', 'email': 'asmaa.abdelfattah@pharm.sohag.edu.eg', 'phone': '+201095727201'}, {'name': 'Engy Wahsh', 'role': 'CONTACT', 'email': 'engywahsh@o6u.edu.eg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Clinical Pharmacy Department, Faculty of Pharmacy, 6 October University', 'class': 'UNKNOWN'}, {'name': 'Faculty of Medicine, Minia University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of clinical pharmacy', 'investigatorFullName': 'Asmaa Abdelfattah Elsayed', 'investigatorAffiliation': 'Beni-Suef University'}}}}