Cardiovascular Effects of Empagliflozine

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tel Aviv University
• Treatments: Empagliflozin

Criteria

Inclusion Criteria:

• Type 2 Diabetes

• HbA1C:7.5-10.

• Age>18 years-80 years

• Cardiovascular risk factor: Ischemic heart disease (IHD)

• Status Post Myocardial Infarct (SPMI),

• Angina Pectoris (AP), stable, unstable AP, Peripheral vascular disease (PVD),

• Cerebro vascular accident (CVA), all > 6 month

• Chronic renal failure (CRF),

• e-GFR > 50 ml/min

• Patients will be required to be on stable glucose-lowering therapy for at least 12 weeks before entering the study.

Exclusion Criteria:

• Age<18 years

• Pregnanacy,breast-feeding.

• eGFR < 45mg/dl

• Type1 Diabetes

• Active urogenital infection , or an infection in the last 6 months.

• Recurrent UTI or genital infections.

• SGLT2 treatment.

• History of ketoacidosis.

• Pulmonary embolism/DVT during the last year.

• Malignancy active, (during the last 10 years).

• Steroid use.