Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-01-10 @ 11:31 AM
Study NCT ID:
NCT03131232
Status:
UNKNOWN
Last Update Posted:
2017-04-27
First Post:
2017-04-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Empagliflozin on Glucose Metabolism, Weight, Blood Pressure and Cardiac Function (NT-proBNP) Should be Investigated
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-24', 'studyFirstSubmitDate': '2017-04-13', 'studyFirstSubmitQcDate': '2017-04-24', 'lastUpdatePostDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effect of empagliflozine on glucose metabolism', 'timeFrame': '6 month', 'description': 'HbA1c in %'}, {'measure': 'The effect of empagliflozine on glucose metabolism', 'timeFrame': '6 month', 'description': 'Body weight in kg'}, {'measure': 'The effect of empagliflozine on glucose metabolism', 'timeFrame': '6 month', 'description': 'BMI in kg/m²'}, {'measure': 'The effect of empagliflozine on glucose metabolism', 'timeFrame': '6 month', 'description': 'blood pressure in mmHg'}, {'measure': 'The effect of empagliflozine on glucose metabolism', 'timeFrame': '6 month', 'description': 'NT-pro BNP in pg/ml'}], 'secondaryOutcomes': [{'measure': 'Frequency of urinary and urogenital infections', 'timeFrame': '6 month', 'description': 'Urinary infection as reported by the patient CRP (Creactive protein) in mg/dl'}, {'measure': 'detection differential regulation of endogenous and exogenous metabolites in addition to circulating proteins by empagliflozin.', 'timeFrame': '6 month', 'description': 'perform metabolomic and proteomic profiling of serum samples'}, {'measure': 'Lipid measurements', 'timeFrame': '6 month', 'description': 'LDL-C in mg/dl HDL-C in mg/dl TG (triglyceride) in mg/dl'}, {'measure': '- echocardiographic parameters (if collected) with determination of the systolic and diastolic left ventricular function', 'timeFrame': '6 month', 'description': 'LV-EF (left ventricular ejection fraction) in % LV (left ventricular) global strain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'In summary, the registry should provide novel insight into potential mechanisms of cardiovascular risk reduction in patients treated with Empagliflozin with an indication of intensified glucose lowering therapy based on their HbA1c level.', 'detailedDescription': 'Patients with diabetes exhibit an increased risk for the development of cardiovascular disease with a significantly impaired prognosis compared to patients without diabetes. Recent data from the EMPA-REG Outcome Trial suggest that treatment with the SGLT-2 inhibitor Empagliflozin reduces cardiovascular events, cardiovascular mortality as well as hospitalization for heart failure in patients with type 2 diabetes and pre-existing cardiovascular disease. Empagliflozin leads to reduction of blood glucose by an increased glucose excretion reduces blood pressure and weight. Still, it remains unclear how empagliflozin led to this pronounced reduction of cardiovascular mortality the EMPA-REG OUTCOME trial. Thus, our registry will analyse various biochemical as well as clinical markers in patients with type 2 diabetes and newly initiated treatment with empagliflozin. and an indication for intensification of glucose lowering therapy with empagliflozin. Patients with an indication for an intensified glucose-lowering therapy (HbA1c \\> 7,5%) will receive 10 mg empagliflozin and we will perform biochemical analyses of blood samples including insulin, glucagon as well as metabolites at baseline as well as after 1 and 6 months. In addition we will assess echocardiographical data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'If possible, all patients of the Department MK1 Uniklinik Aachen who are treated with empagliflozine', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetes mellitus II Patients with whom an empagliflozine treatment is to be initiated from a clinical indication\n\nExclusion Criteria:\n\n* Inability to consent to the study'}, 'identificationModule': {'nctId': 'NCT03131232', 'acronym': 'Empa', 'briefTitle': 'The Effect of Empagliflozin on Glucose Metabolism, Weight, Blood Pressure and Cardiac Function (NT-proBNP) Should be Investigated', 'organization': {'class': 'OTHER', 'fullName': 'RWTH Aachen University'}, 'officialTitle': 'The Aim of This Study is to Investigate the Protective Effect of Empagliflozin on the Cardiovascular System in Diabetes Mellitus Patients', 'orgStudyIdInfo': {'id': '15-152'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Dirk DM Müller Wieland, Scientific Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Coordination Center for Clinical Study'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RWTH Aachen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}