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Clinical Trial Details

Trial ID: L4043
Source ID: NCT04242758
Associated Drug: Dapagliflozin 10 Mg
Title: Phthalates Exposure in Type 2 Diabetic Patients and Diuretic Therapy
Acronym: PURITY
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Renal Function Disorder|Glucose Metabolism Disorders
Interventions: DRUG: Dapagliflozin 10 MG|DRUG: Hydrochlorothiazide 12.5mg
Outcome Measures: Primary: Urinary Phthalates concentration, Exposure to phthalates assessed through urinary concentration of phthalates metabolites spot and 24-hours, Changes between baseline and 1 month|Urinary Phthalates concentration, Exposure to phthalates assessed through urinary excretion spot and 24-hours, Changes between baseline and 3 month | Secondary: Fasting glucose, Fasting glucose measured in a fasting morning blood sample, 1 and 3 months|Glycated Haemoglobin, HbA1c in a fasting measured in a morning blood sample, 1 and 3 months|Renal function, Using creatinine measured in a fasting morning blood sample and estimated by eGFR (calculated with the CDK-EPI formula), 1 and 3 months|Macrovascular events, Number of participants with MACE events (Stroke, Acute Myocardial Infarction, Unstable Angina, Revascularization), 1 and 3 months|Albumin excretion, Measured by urinary albumin/creatinine ratio, 1 and 3 months
Sponsor/Collaborators: Sponsor: University of Pisa
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2019-06-04
Completion Date: 2020-04-01
Results First Posted:
Last Update Posted: 2020-01-27
Locations: University of Pisa, Pisa, 56125, Italy
URL: https://clinicaltrials.gov/show/NCT04242758