CTRI/2022/10/046795尚未招募不适用
Study on antidyslipidemic and insulin sensitising effects of saroglitazar in patients with diabetic dyslipidemia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To study the effects of Saroglitazar on
研究概览
简要总结
Saroglitazar is a Dual PPAR agonist approved for use in treatment of diabetic dyslipidemia
animal model studies indicated that saroglitazar has a role in improving insulin sensitivity
we are going to see the effect of saroglitazar in terms if insulin sensitivity (by neasurement of HOMA-IR) and lipid profile in patients of Diabetic dyslipidemia with low dose statins
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with diabetic dyslipidemia with fasting triglycerides > 200-400 who are being treated with any of non insulin secretogogues( alpha glucose daze inhibitors, biguanides, SGLT-2 inhibitors) and low dose statin for at least 3 months.
排除标准
- •patients on insulin, glitazar, glitazone, insulin secretogagues (sulfonylureas) history of Thyroid disease, cardiac illness, liver disease (s.bilirubin > 2 times Upper normal limits), renal dysfunction(s.creatinine > 1.2mg/dL) comorbid serious illness like tuberculosis, malignancy, HIV.
- •Pregnant and nursing mother.
结局指标
主要结局
To study the effects of Saroglitazar on
时间窗: 0 and 84th day after drug intake
1. Insulin Resistance
时间窗: 0 and 84th day after drug intake
2. Lipid profile
时间窗: 0 and 84th day after drug intake
in patients with Diabetic Dyslipidemia
时间窗: 0 and 84th day after drug intake
次要结局
- study the effects of Saroglitazar on(1.HbA1c levels)
研究者
研究点 (1)
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