Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2026-03-06 @ 1:59 AM
Study NCT ID:
NCT03784703
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2018-12-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Type 2 Diabetic Patients Maintained on Statin Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D013607', 'term': 'Tablets'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'prospective, double blind trial'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '160 patients were randomly assigned to receive either 40 mg per day atorvastatin tablets (ATROVA group, n= 80) or 10 mg per day Rosuvastatin tablets (ROSUVA group, n= 80) as recommended in NCEP ATP III (21). Patients included in the study were maintained on oral hypoglycemic agents (OHA) according to their treatment regimen.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-30', 'studyFirstSubmitDate': '2018-12-13', 'studyFirstSubmitQcDate': '2018-12-21', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hs-CRP (pg/mL)', 'timeFrame': '6 months', 'description': 'biomarkers that linking the inflammatory hypothesis with diabetes mellitus and atherosclerosis.'}, {'measure': 'sortilin (ng/mL)', 'timeFrame': '6 months', 'description': 'Serum Level'}, {'measure': 'adiponectin (ng/mL)', 'timeFrame': '6 months', 'description': 'Serum Level'}, {'measure': 'leptin (ng/mL)', 'timeFrame': '6 months', 'description': 'Serum Level'}], 'secondaryOutcomes': [{'measure': 'glucose level', 'timeFrame': '6 months', 'description': 'fasting blood glucose (FBG) (mg/mL)'}, {'measure': 'glycated hemoglobin', 'timeFrame': '6 months', 'description': 'glycated hemoglobin (Hb A1c%)'}, {'measure': 'total cholesterol', 'timeFrame': '6 months', 'description': 'TCH: total cholesterol (mg/dL)'}, {'measure': 'low density lipoprotein-cholesterol', 'timeFrame': '6 months', 'description': 'LDL-C: low density lipoprotein-cholesterol (mg/dL), HDL-C: high density lipoprotein-cholesterol (mg/dL); Triglycerides (mg/dL).'}, {'measure': 'high density lipoprotein-cholesterol', 'timeFrame': '6 months', 'description': 'HDL-C: high density lipoprotein-cholesterol (mg/dL); Triglycerides (mg/dL).'}, {'measure': 'Triglycerides', 'timeFrame': '6 months', 'description': 'Triglycerides (mg/dL).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adiponectin', 'Sortilin', 'Leptin', 'Dyslipidemia', 'Diabetes type II', 'Rosuvastatin', 'Atorvastatin'], 'conditions': ['Dyslipidemia Associated With Type II Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '24354929', 'type': 'BACKGROUND', 'citation': 'Krysiak R, Zmuda W, Okopien B. The effect of simvastatin-ezetimibe combination therapy on adipose tissue hormones and systemic inflammation in patients with isolated hypercholesterolemia. Cardiovasc Ther. 2014 Apr;32(2):40-6. doi: 10.1111/1755-5922.12057.'}]}, 'descriptionModule': {'briefSummary': 'Patients with diabetes mellitus (DM) are at increased risk of atherosclerotic cardiovascular disease (ACVD). The achievement of the LDL-C target with statins for the reduction of ACVD risk is recommended. However, the risk is still present. Therefore, we investigated the impact of high sensitivity C-reactive protein (hsCRP), sortilin, adiponectin and leptin biomarkers that linking inflammatory hypothesis of diabetes mellitus and atherosclerosis in diabetic patients treated with rosuvastatin and atrovastatin. Methods: Based on exclusion criteria, 150 type 2 diabetic patients were eligible and randomly assigned to receive either 40 mg per day atorvastatin (ATROVA group, n= 80) or 10 mg per day rosuvastatin (ROSUVA group, n= 80) for 6 months.', 'detailedDescription': 'a prospective, double blind trial, conducted between January 2018 and January 2020. Participants were enrolled if they had moderate cardiovascular risk (Framingham risk score of 10-20%), in other words 2 or more major risk factors for coronary artery disease (CAD), and LDL-cholesterol level ≥100 mg/dl. All patients gave informed consent before entering the study. Of 150 patients were randomly assigned to receive either 40 mg per day atorvastatin tablets (ATROVA group, n= 80) or 10 mg per day Rosuvastatin (Rosuvastatin Calcium®, Chemipharm Co. Cairo, Egypt) tablets (ROSUVA group, n= 80) as recommended in NCEP ATP III (21). Patients included in the study were maintained on oral hypoglycemic agents (OHA) according to their treatment regimen. Clinical and biochemical assessment was done at baseline and after 6 months. Serum High-sensitivity CRP (hsCRP), sortilin, Adiponectin and Leptin level was determined using ELISA Kit. Blood pressure (BP) and anthropometrical parameters, such as body-mass index (BMI) were calculated using the equation (BMI = weight (kg)/height (m2). Blood pressure was measured twice, after keeping participants in a sitting position for 15 min. The mean value of two consecutive measurements with 5 min intervals was used for study purposes. HbA1c% was determined by ion exchange method. Serum triglycerides (TGs), total cholesterol (TCH), and high-density lipoprotein cholesterol (HDL-C) were determined colorimetrically. Low-density lipoprotein-cholesterol (LDL-C) was calculated according to Friedewald formula. Atherogenic Index (AI) is calculated through the following: Atherogenic Index = TCH/HDL-C as TCH/HDL-C ratio is an excellent CVD risk predictor and a good biomarker for deciding on the intensity and the need for therapeutic intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type II diabetic patients with hypercholesterolemia\n\nExclusion Criteria:\n\n* liver impairment,\n* renal insufficiency,\n* coronary artery disease,\n* metabolic disorders,\n* type I diabetes,\n* autoimmune diseases, cancer, infection,\n* use of anti-inflammatory drugs,\n* recent major surgery,\n* weight-loss or modified anti-hypertensive medications 12 weeks or less prior to enrolment,\n* ongoing or previous use of lipid-lowering medications (including other statins, fibric acid derivatives, nicotinic acid, cholestyramine, ezetimibe or omega-3 fatty acids) and contraindications to the use of statins.'}, 'identificationModule': {'nctId': 'NCT03784703', 'briefTitle': 'Type 2 Diabetic Patients Maintained on Statin Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Damanhour University'}, 'officialTitle': 'Efficacy of Atorvastatin Versus Rosuvastatin on LV Function and Inflammatory Biomarkers in Type 2 Diabetic Patients With Dyslipidemia', 'orgStudyIdInfo': {'id': 'Statin Therapy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Atrovastatin', 'description': 'atorvastatin (40 mg per day) for 6 months', 'interventionNames': ['Drug: Atorvastatin 40 Mg Oral Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Rosuvastatin', 'description': 'Rosuvastatin (10 mg per day) for 6 months', 'interventionNames': ['Drug: Rosuvastatin 10 Mg Oral Tablet']}], 'interventions': [{'name': 'Atorvastatin 40 Mg Oral Tablet', 'type': 'DRUG', 'otherNames': ['Atorvastatin 40mg tablet per day'], 'description': '40 mg per day atorvastatin (ATROVA group, n= 80) for 6 months', 'armGroupLabels': ['Atrovastatin']}, {'name': 'Rosuvastatin 10 Mg Oral Tablet', 'type': 'DRUG', 'otherNames': ['Resovastatin 10 mg daily'], 'description': '10 mg per day rosuvastatin (ROSUVA group, n= 80) for 6 months', 'armGroupLabels': ['Rosuvastatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'country': 'Egypt', 'facility': 'Tanta University Hospital', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'Rehab Werida, Lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Damanhour University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Damanhour University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tanta University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Pharmacy Lecturer', 'investigatorFullName': 'Rehab Werida', 'investigatorAffiliation': 'Damanhour University'}}}}