Rationale and design of an investigator-initiated, multicenter, prospective open-label, randomized trial to evaluate the
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Cardiovascular Diabetology Open Access
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Rationale and design of an investigator‑initiated, multicenter, prospective open‑label, randomized trial to evaluate the effect of ipragliflozin on endothelial dysfunction in type 2 diabetes and chronic kidney disease: the PROCEED trial Atsushi Tanaka1* , Michio Shimabukuro2, Yosuke Okada3, Kazuhiro Sugimoto4, Akira Kurozumi5, Keiichi Torimoto3, Hiroyuki Hirai2,6 and Koichi Node1* on behalf of the PROCEED trial investigators
Abstract Background: Type 2 diabetes (T2D) is associated with renal impairment and vascular endothelial dysfunction. Therefore, this pathological connection is an important therapeutic target. Recent cardiovascular and renal outcome trials demonstrated that sodium glucose cotransporter 2 inhibitors (SGLT2is) consistently reduced the risks of cardiovascular and renal events and mortality in patients with T2D and various other background risks including chronic kidney disease (CKD). However, the precise mechanisms by which SGLT2is accords these therapeutic benefits remain uncertain. It is also unknown whether these SGLT2is-associated benefits are associated with the amelioration of endothelial dysfunction in patients with T2D and CKD. Methods: The PROCEED trial is an investigator-initiated, prospective, multicenter, open-label, randomized-controlled trial. The target sample size is 110 subjects. After they furnish informed consent and their endothelial dysfunction is confirmed from their decreased reactive hyperemia indices (RHI), eligible participants with T2D (HbA1c, 6.0–9.0%) and established CKD (30 mL/min/1.73 m2 ≤ estimated glomerular filtration ratio [eGFR]
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