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Clinical Trial Details

Trial ID: L2856
Source ID: NCT04183868
Associated Drug: Empagliflozin 10 Mg
Title: Effects of empagliFlozin on myocardIal metabOlic Rate of glucosE Estimated Through 18FDG PET (FIORE Study)
Acronym: FIORE
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes|Cardiovascular Risk Factor
Interventions: DRUG: Empagliflozin 10 MG|DRUG: Glimepiride 2 mg
Outcome Measures: Primary: Change of myocardial metabolic rate of glucose, To assess whether empagliflozin treatment is able to determine a change of myocardial metabolic rate of glucose estimated through hyperinsulinemic euglycemic clamp 18FDG-PET scan, than glimepiride treatment (both in addition to metformin), in patients with T2DM without a history of coronary heart disease., Baseline, after 26 and 52 weeks | Secondary: Change of glycemic parameters, To compare empagliflozin and glimepiride (in addition to metformin) on glycemic parameters (fasting glucose, HbA1c)., Baseline, after 26 and 52 weeks|Change of insulin sensitivity, To compare empagliflozin and glimepiride regimens on change of insulin sensitivity, assessed by hyperinsulinemic euglycemic clamp., Baseline, after 26 and 52 weeks|Change of blood pressure, To compare the respective impact of empagliflozin and glimepiride on systolic and diastolic blood pressure assessed at baseline and after 26 weeks, Baseline, after 26 and 52 weeks|Change of left ventricular systolic and diastolic function, To compare empagliflozin and glimepiride on change of left ventricular systolic and diastolic function, assessed by echocardiogram, Baseline, after 26 and 52 weeks|Change of pro-BNP, To compare the respective impact of empagliflozin and glimepiride on pro-BNP, Baseline, after 26 and 52 weeks|Change of inflammatory state, To compare the respective impact of empagliflozin and glimepiride on high sensitivity C-reactive protein \[hsCRP), Baseline, after 26 and 52 weeks|Change of cardiovascular biomarkers, To compare the respective impact of empagliflozin and glimepiride on cardiovascular biomarkers (troponin T), Baseline, after 26 and 52 weeks|Change of heart rate variability, To compare empagliflozin and glimepiride on change of heart rate variability assessed by Holter ECG, Baseline, after 26 and 52 weeks|Change of lipid profile, To compare the respective impact of empagliflozin and glimepiride on lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides), Baseline, after 26 and 52 weeks
Sponsor/Collaborators: Sponsor: University of Catanzaro
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 26
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2016-04
Completion Date: 2021-10
Results First Posted:
Last Update Posted: 2023-01-18
Locations: Universital Hospital Mater Domini, Catanzaro, 88100, Italy
URL: https://clinicaltrials.gov/show/NCT04183868