A Comparitive study of Dapagliflozin Vs Pioglitazone in Patients of Non Alcoholic Fatty liver disease with Type 2 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Achieving the target level of HbA1C 6.5%
研究概览
简要总结
TITLE: A COMPARATIVE STUDY OF DAPAGLIFLOZIN VS PIOGLITAZONE IN PATIENTS OF NON ALCOHOLIC FATTY LIVER DISEASE WITH TYPE 2 DIABETES MELLITUS BACKGROUND: NAFLD Is a condition in which excess fat builds up in the liver.This buildup of fat is not caused by heavy alcohol use. DAPAGLIFLOZIN An inhibitor of sodium-glucose co-transporter 2 (SGLT2),decreases blood glucose levels without the use of insulin by improving renal glucose excretion. PIOGLITAZONE Is an oral drug It works by stimulating nuclear receptors known as peroxisome proliferator-activated receptor gamma(PPAR-γ) and modifies gene expression through binding to PPAR-γ, which has several consequences. MATERIAL AND METHODS: The study employed a prospective, randomized, open-label design and was conducted at ERA’S Lucknow Medical College & Hospital, with collaboration from the Department of Pharmacology, Medicine, and Radiology. It involved a total sample size of 108 patients, evenly distributed with 54 patients in each group. The study continued for a duration of 18 months
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
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1 NAFLD Fibrosis Score(Stage 1 to Stage 3) 2 USG (Grade 2 & Grade 3 fatty liver) 3 HbA1C 6.5% & above 4 BMI 23 kg/m² & above 5 Type 2 diabetes mellitus patient on treatment of metformin (upto 2g/day).
排除标准
- •1 Patient with heart failure, kidney failure, malignancy 2 Pregnant & Lactating mothers 3 Habitual drinkers 4 Contraindication to dapagliflozin and pioglitazone 5 Use of steroid &/ or other immunosuppressor 6 H/o mental illness or inability to co operate.
结局指标
主要结局
Achieving the target level of HbA1C 6.5%
时间窗: 3 week 6 week 12 week
次要结局
- Secondary Outcome:(• Assessment of glycemic control (HbA1c) in participants.)
研究者
Babra
Eras Lucknow Medical College