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Clinical Trial Details

Trial ID: L2426
Source ID: NCT03918148
Associated Drug: Sglt-2i
Title: Gliflozins and Cardiovascular Risk Factors in Type 2 Diabetes (GIOIA)
Acronym: GIOIA
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: SGLT-2i|DRUG: DPP-4i
Outcome Measures: Primary: Carotid intima-media thickness (CIMT), Progression (increase in mean CIMT in millimeters \[mm\]) or regression (reduction \> o = 0.020 mm on mean CIMT) after 2 years of follow-up, 24 months|Myocardial stiffness indexes, Change from baseline in: Left Ventricular Ejection Fraction (LVEF) in percentage (%), Diastolic Left Ventricular Dimension (LVDs) in centimeters (cm) Interventricular Septum thickness (IVS) in cm left vetricular posterior wall thickness (PWs) in cm, 24 months|Urinary albumin to creatinine ratio excretion, Development of microalbuminuria in normoalbuminuric patients at baseline or development of macroalbuminuria in patients with microalbuminuria at baseline; regression of microalbuminuria to normoalbuminuria or regression of macroalbuminuria to microalbuminuria, 24 months | Secondary: Weight, Change in body weight in kilograms (kg) from baseline, 24 months|Body mass index (BMI), Change in body mass index in Kg/mq from baseline, 24 months|Waist circumference (WC), Change in waist circumference in cm from baseline, 24 months|Blood pressure, Change in systolic and dyastolic blood pressure in mmHg from baseline, 24 months|estimated Glomerular filtration rate (eGFR), Change in estimated glomerular filtration rate in mI/min/1.73 mq from baseline, 24 months | Other: HbA1c, Change in HbA1c in % from baseline, 24 months|Mean amplitude glucose excursions (MAGE), Change in MAGE in mmol/L from baseline, 24 months|Lipid profile, Change in total cholesterol, tryglicerides, HDL-cholesterol, and LDL-cholesterol in mg/dL from baseline, 24 months
Sponsor/Collaborators: Sponsor: University of Campania Luigi Vanvitelli
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 1150
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2018-01-15
Completion Date: 2023-12-31
Results First Posted:
Last Update Posted: 2024-04-19
Locations: Unit of Diabetes, Naples, Campania, 80138, Italy
URL: https://clinicaltrials.gov/show/NCT03918148