Effect of Lobeglitazone on arterial stiffness in comparison to pioglitazone in patients with type 2 diabetes : a pilot randomized controlled trial
试验速览
- 阶段
- 不适用
- 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 lobeglitazone vs pioglitazone on arterial stiffness as an add on therapy to preexisting anti diabetic drugs in patients with type 2 diabetes
研究概览
简要总结
Vascular stiffness measured by Pulse Wave Velocity is a marker of atherosclerosis. Diabetes mellitus is a risk factor form developing atherosclerosis and relater complication. Studies have show that pioglitazone which belongs to a class of drugs called thiozolidinedione, can improve glycemic control and reduces risk of major adverse cardiovascular events. Lobeglitazone which is a drug belonging to the same class as pioglitazone was launched in 2022 in India. Studies have showed that lobeglitazone can improve glycemic control. A few preclinical trials have shown that lobeglitazone can improve vascular stiffness. Our study aims to fill this knowledge gap of wheather Lobeglitazone can reduce arterial stiffness as compared to pioglitazone.
Methodolgy
A total of 46 diabetic patients will be randomized into two groups. The intervention arm will receive lobeglitazone and the compartator arm will receive pioglitazone. Vascular stiffness will be measured at baseline and after 6 months of therapy and the changes will be analysed.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Type 2 diabetes mellitus with HbA1c between 7 to 9 Willing to provide informed consent.
排除标准
- •Pregnancy or breast feeding Patient with eGFR less than 45 mL/min Patients with cardiac rhythm disorders or heart failure Baseline AST and ALT more than 3 times of upper limit Patient with BMI more than 40 Patient with hemoglobin less than 8g/dL History of any spine fractures Patients with malignancies Patients on insulin, SGLT 2i and GLP 1 agonist therapy.
结局指标
主要结局
To evaluate the effect of lobeglitazone vs pioglitazone on arterial stiffness as an add on therapy to preexisting anti diabetic drugs in patients with type 2 diabetes
时间窗: 6 months
次要结局
- HbA1c, fasting blood sugar, post prandial blood sugar(6 months)
- Proportion of patients acheiving HbA1c less than 7 percentage(6 months)
研究者
Dr Arindam Naskar
School of Tropical Medicine