Effect of Saroglitazar on vascular stiffness in patients with Diabetic dyslipidemia: a Pilot Randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- To evaluate the effect of Saroglitazar vs standard of care on arterial stiffness in patients of T2DM and hyper
研究概览
简要总结
Saroglitazar is indicated for treatment of diabetic dyslipidemia ( mainly Hypertriglyceridemia) and Metabolic Dysfunction Associated Fatty Liver Disease (MAFLD).Even though , this molecule is been available for more than one decade no study done has been done on its cardiovascular benefit. Through this study we would like to evaluate if Saroglitazar has any effect on vascular stiffness, which is one of the marker of atherosclerosis and further laying foundation for any future studies exploring the benefits of Saroglitazar.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult subjects (more than 18 years to less than 65 of age) of any gender Established diagnosis of type 2 diabetes mellitus Serum fasting triglyceride more than 150mg/dl On Statin therapy for at least 6 month Willing to providing written informed consent.
排除标准
- •Type 1 diabetes Pregnancy or breastfeeding lady Triglyceride level more than 500 mg/dL Any concomitant thyroid disorders Patients having estimated GFR less than 45 ml/min/1.73m2 Patients known Heart failure (Stage III or IV) Severe liver dysfunction(Child Pugh C) Baseline AST, ALT more than 3 times of upper limit Hemoglobin less than 8 gm/dL Tobacco abusers, Alcoholic and any kind of substance abusers Patients with malignancy and/or on chemotherapy Patients with infectious disease like HIV, Hepatitis B, Hepatitis C • On other Triglyceride lowering therapy ( Fenofibrate, Icosapent Ethyl) • Patients on oral contraceptive pills, antipsychotic drugs • Patients taking steroids.
结局指标
主要结局
To evaluate the effect of Saroglitazar vs standard of care on arterial stiffness in patients of T2DM and hyper
时间窗: 6 months
tryglyceridemia ( TG more than 150mg/dL) from baseline to week 24
时间窗: 6 months
次要结局
- To compare any changes from baseline to week 24 in(1. Lipid Profile)
研究者
Dr Arindam Naskar
School of Tropical Medicine