Cardiovascular Effects of Empagliflozine
- Sponsor
- Tel Aviv University
- Study ID
- NCT02918591
- Status
- Unknown
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Empagliflozine — DRUGAll 6type 2 diabetic participant will receive treatment with Empagliflozine during 2 month
Study Details
It has been shown that in patients with type 2 diabetes (T2D) at high risk for cardiovascular disease (CVD) who received Empagliflozine as compared with placebo had a lower rate of death from cardiovascular causes, non-fatal MI, or non-fatal strokes as well as death from any cause and hospitalization for heart failure. This lower incidence of cardiovascular disease in individuals treated with selective inhibitor of renal sodium-glucose co-transporters (SGLTs) has been associated with reduction of blood levels of fibroblast growth factor 23 (FGF23) and with increase of blood levels of Klotho. Therefore we will investigate the blood levels of fibroblast growth factor 23 (FGF23) and of Klotho in type 2 diabetic patients treated with Empagliflozine The investigators anticipate that patients treated with Empagliflozine will have decreased levels of FGF23 and increased levels of Klotho which would provide a good explanation for the beneficial cardiovascular effects of selective inhibitors of renal sodium-glucose co-transporters (SGLTs)
Key Dates
- Start date
- Nov 30, 2017
- Status verified
- Oct 2017
- Primary completion
- Mar 31, 2018
- Completion
- Dec 31, 2018
Study Design
- Enrollment
- 10 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: EmpagliflozineAll type 2 diabetic participant will be treated during 2 month with Empagliflozine 10 to 25 mg daily during 2 month.
Primary Outcome Measure
Change of Soluble Klotho [ Time Frame: up to 2 months ]
Central Contacts
- Julio Wainstein, MD972506296940
- Daniela Jakubowicz508105552
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