Effect of Bempedoic acid on arterial Stiffness in patients with Diabetic dyslipidemia: a Pilot Randomized controlled trial

ARINDAM NASKAR1 个研究点分布在 1 个国家目标入组 48 人开始时间: 2026年1月16日最近更新: 2026年1月5日

试验速览

阶段: 2 期
状态: 招募中
发起方
入组人数: 48
试验地点: 1

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

A preclinical study has demonstrated Bempedoic acid may have favourable effect on arterial stiffness in male Sprague-Dawley Rats. However there is lack of human trial in existing literature to demonstrate effect of Bempedoic acid on vascular stiffness. Our study aims to frill this knowledge gap whether Bempedoic acid can actually reduce arterial stiffness that may add new insight to existing literature

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: None

入排标准

年龄范围: 40.00 Year(s) 至 75.00 Year(s)（—）
性别: All

入选标准

•Established diagnosis of type 2 diabetes mellitus (T2DM) [As per American Diabetes Association criteria for diagnosis of T2DM] Serum LDL more than 70 mg/dl with Atorvastatin (20mg daily) therapy for at least 6 months Willing to providing written informed consent.

排除标准

•Patients having estimated GFR less than 30 ml/min/1.73m2 by CKD-EPI criteria Patients known Heart failure (Stage III or IV) Severe liver dysfunction (Child Pugh C) Baseline AST and ALT more than 3 times of upper limit Hemoglobin less than 8 gm/dl Tobacco abusers and any kind of substance abusers Patients with malignancy and/or on chemotherapy Patients with infectious disease like HIV Hepatitis B and Hepatitis C Hyperuricemia (Male more than 7 mg/dl, female more than 6 mg/dl) History of Tendon rupture.

研究者

发起方

ARINDAM NASKAR

申办方类型

Other [self]

责任方

Principal Investigator

主要研究者

Dr Arindam Naskar

School of Tropical Medicine

研究点 (1)

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