Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-30 @ 1:22 AM
Study NCT ID:
NCT07083232
Status:
COMPLETED
Last Update Posted:
2025-08-14
First Post:
2025-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Sitagliptin, Pioglitazone and Dapagliflozine on Myocardial Infarction in Diabetic Rats
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013311', 'term': 'Streptozocin'}, {'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}, {'id': 'C014635', 'term': 'lactitol'}, {'id': 'D000077205', 'term': 'Pioglitazone'}], 'ancestors': [{'id': 'D009607', 'term': 'Nitrosourea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009603', 'term': 'Nitroso Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-09', 'studyFirstSubmitDate': '2025-07-16', 'studyFirstSubmitQcDate': '2025-07-16', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blood glucose', 'timeFrame': 'one week'}], 'secondaryOutcomes': [{'measure': 'tumor necrosis factor-α', 'timeFrame': 'One week'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myocardial Infarction', 'Diabetic', 'Rats', 'Sitagliptin', 'Pioglitazone', 'Dapagliflozine'], 'conditions': ['Diabetic', 'Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to evaluate the prophylactic effect of Sitagliptin, Pioglitazone and Dapagliflozine on Isoprenaline induced myocardial infarction in type II diabetic rats.', 'detailedDescription': 'The American Diabetes Association defined diabetes mellitus as a group of metabolic diseases characterized by hyperglycemia resulting from defects in insulin secretion, insulin action or both. The chronic hyperglycemia of diabetes is associated with long-term damage, dysfunction and failure of different organs, especially the eyes, kidneys, nerves, heart and blood vessels.\n\nMyocardial ischemia represents a condition of sufferance for cardiomyocytes due to coronary blood flow reduction as compared to their metabolic needs, and it may exhibit through several clinical conditions.\n\nPeople with type 2 diabetes mellitus are at increased risk of cardiovascular disease, heart failure and death, as compared with the general population. Studies show that the excess risks associated with diabetes mellitus are mediated primarily by hyperglycemia and overall poor risk factor control. Effective treatment of traditional cardiovascular risk factors has reduced the excess risk of atherosclerotic cardiovascular disease , such as acute myocardial infarction and stroke in people with type 2 diabetes mellitus.\n\nIn the last two decades, several studies have demonstrated reductions in the risk of cardiovascular outcomes and mortality in patients with type 2 diabetes mellitus with improved glucose and cholesterol-lowering therapies. Nevertheless, macrovascular disease remains the most common cause of death in type 2 diabetes mellitus patients and new diabetes therapies are highly desired, especially if they can offer cardiovascular benefits.\n\nSitagliptin is a potent and highly selective dipeptidyl peptidase-4 competitive inhibitor that does not affect the closely related enzymes dipeptidyl peptidase-8 or dipeptidyl peptidase-9 at therapeutic concentrations.\n\nSitagliptin found to enhance circulating glucagon-like peptide-1 levels through inhibition of dipeptidyl peptidase -IV activity.\n\nwhich, in turn, provides cardiovascular protection probably through the anti-inflammatory and anti-atherosclerotic activities of glucagon-like peptide-1. Reduces blood glucose levels, in either the postprandial or the fasting state.\n\nMultiple studies have suggested that pioglitazone, a peroxisome proliferatoractivated receptor γ agonist, used as an insulin-sensitizing agent in the treatment of type 2 diabetes mellitus , may have anti-atherosclerotic effects.\n\nThe mechanism of action of dapagliflozine influences a number of cardiovascular disease risk factors, in particular, decreasing blood pressure, reducing body weight (predominantly through reductions in total body fat mass, including visceral adipose tissue), reducing waist circumference, and lowering albuminuria and serum uric acid levels, with allow intrinsic risk of hypoglycemia.\n\nIsoprenaline is a potent β-adrenergic agonist, increases the myocardial oxygen demand by mixture of its positive inotropic and chronotropic actions. Administration of isoprenaline in high doses to animals produces infarct like lesions in the heart similar to those present in myocardial infatction in humans.\n\nThe aim of the present study is to evaluate the prophylactic effect of Sitagliptin, Pioglitazone and Dapagliflozine on Isoprenaline induced myocardial infarction in type II diabetic rats.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 50 adult male albino rats obtained from (Experimental Animal Breeding Farm, assuit -Cairo) weighing between 150- 200 g (at the beginning of the study)\n\nExclusion Criteria:\n\n* Female rats --Weight \\>200g'}, 'identificationModule': {'nctId': 'NCT07083232', 'briefTitle': 'The Effect of Sitagliptin, Pioglitazone and Dapagliflozine on Myocardial Infarction in Diabetic Rats', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Comparative Study on the Effect of Sitagliptin, Pioglitazone and Dapagliflozine on Myocardial Infarction Induced Experimentally in Diabetic Rats', 'orgStudyIdInfo': {'id': 'MD/AZ.AST./PHA006/8/231/5/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'standard normal diet and water group', 'description': 'Group I: formed of normal animals. They were allowed standard normal diet and water. They received no drugs.', 'interventionNames': ['Dietary Supplement: standard normal diet']}, {'type': 'EXPERIMENTAL', 'label': 'low dose Streptozotocin group', 'description': 'Group II: Non-treated diabetic rats; diabetes was induced by administration of 20% fructose solution in drinking water for 2 weeks, then intra peritoneal injection of a low dose STZ (40 mg/kg b.w.)', 'interventionNames': ['Drug: low dose Streptozotocin']}, {'type': 'EXPERIMENTAL', 'label': 'Sitagliptin group', 'description': 'Group III: Sitagliptin treated diabetic group sitagliptin was administered by gastric gavage in a dose 10mg/ kg /day for 4 weeks', 'interventionNames': ['Drug: Sitagliptin (Novartis, USA)']}, {'type': 'EXPERIMENTAL', 'label': 'Pioglitazone group', 'description': 'Group IV : Pioglitazone treated diabetic group ; Pioglitazone was administered by gastric gavage in a dose 10 mg/ kg /day for 4 weeks', 'interventionNames': ['Drug: Pioglitazone hydrochloride (Unipharma., Egypt)']}, {'type': 'EXPERIMENTAL', 'label': 'Dapagliflozine group', 'description': 'Group V : Dapagliflozine treated diabetic group (G5); Dapagliflozine was administered by gastric gavage in a dose 1mg/ kg /day for 4 weeks', 'interventionNames': ['Drug: Dapagliflozine hemihydrate (Janssen, USA)']}], 'interventions': [{'name': 'standard normal diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Group I: formed of normal animals. They were allowed standard normal diet and water. They received no drugs', 'armGroupLabels': ['standard normal diet and water group']}, {'name': 'low dose Streptozotocin', 'type': 'DRUG', 'description': 'Non-treated diabetic rats; diabetes was induced by administration of 20% fructose solution in drinking water for 2 weeks, then intra peritoneal injection of a low dose STZ (40 mg/kg b.w.), was done', 'armGroupLabels': ['low dose Streptozotocin group']}, {'name': 'Sitagliptin (Novartis, USA)', 'type': 'DRUG', 'description': 'Sitagliptin treated diabetic group sitagliptin was administered by gastric gavage in a dose 10mg/ kg /day for 4 weeks', 'armGroupLabels': ['Sitagliptin group']}, {'name': 'Pioglitazone hydrochloride (Unipharma., Egypt)', 'type': 'DRUG', 'description': 'Pioglitazone treated diabetic group (G4); Pioglitazone was administered by gastric gavage in a dose 10 mg/ kg /day for 4 weeks', 'armGroupLabels': ['Pioglitazone group']}, {'name': 'Dapagliflozine hemihydrate (Janssen, USA)', 'type': 'DRUG', 'description': 'Dapagliflozine treated diabetic group (G5); Dapagliflozine was administered by gastric gavage in a dose 1mg/ kg /day for 4 weeks', 'armGroupLabels': ['Dapagliflozine group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Alazher University.assuit Branch', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of pharmacology', 'investigatorFullName': 'El Shazly Abdelaal Mohaseb', 'investigatorAffiliation': 'Al-Azhar University'}}}}