A Prospective, Randomized Trial to Compare saroGLitazar With pioglitAZone in Nonalcoholic Fatty livEr Disease (GLAZED Trial)
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in the NAFLD fibrosis score
研究概览
简要总结
Non Alcoholic Fatty Liver Disease (NAFLD) is considered as the component of metabolic syndrome. The prevalence of the same has been increasing rapidly in India, along with an increase in the prevalence of diabetes and obesity. Insulin resistance is the key underlying pathogenetic mechanism of NAFLD. NAFLD accounts for significant morbidity and mortality and the therapeutic options are limited. Insulin sensitizing drugs are used in the management of NAFLD.
详细描述
The therapeutic options for the management of nonalcoholic fatty liver disease (NAFLD) include lifestyle modifications, insulin sensitizers, vitamin E, antioxidants and cytoprotective agents. Glitazones are insulin sensitizing drugs and act by stimulating the PPAR gamma receptors. The drugs like Pioglitazone and Rosiglitazone have shown conflicting results in the NAFLD trials. Dual PPAR stimulators (PPAR gamma and PPAR alfa) are known as the "Glitazars" and are useful in simultaneously controlling the hyperglycemia, dyslipidemia and insulin resistance. Saroglitazar is the first drug approved in the investigators country for the management of diabetic dyslipidemia. The investigators plan to study the efficacy of this drug in comparison to Pioglitazone in patients of NAFLD over a period of 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Drug naive patients with NAFLD diagnosed on ultrasonography, BMI > 23 kg/m2 and ALT > 1.5 times the upper limit of normal
排除标准
- •Use of any drugs other than lifestyle modification for NAFLD, HbA1c > 8% FBS>200, Bilirubin > 1.5 mg/dL
- •Any illness likely to cause transaminitis and positive viral markers
研究组 & 干预措施
Saroglitazar Group
Tab Saroglitazar 4 mg oral daily fixed dose for 24 weeks
干预措施: Saroglitazar (Drug)
Pioglitazone Group
Tab Pioglitazone 30 mg daily fixed dose for 24 weeks
干预措施: Pioglitazone (Drug)
结局指标
主要结局
Change in the NAFLD fibrosis score
时间窗: At baseline and the end of 24 weeks
次要结局
- Change in body composition(At baseline and the end of 24 weeks)
- Change in insulin resistance(At baseline and the end of 24 weeks)
- Change in lipid profile(At baseline and the end of 24 weeks)
- Change in HbA1c(At baseline and the end of 24 weeks)
研究者
Hari Kumar
Endocrinologist
Command Hospital, India