Effect of Dapagliflozin on Liver and Body Fat and Insulin Resistance in Patients with Type-2 Diabetes and Non-Alcoholic Fatty Liver Disease
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.To study the effect of Dapagliflozin 10 mg for 6 months, in patients of NAFLD with T2DM on liver fat signal fraction and fibrosis scores
研究概览
简要总结
Type 2 Diabetes Mellitus (T2DM) and Non-Alcoholic Fatty Liver Disease (NAFLD) commonly coexist as part of Metabolic Syndrome, leading to significant cardiovascular morbidity and mortality. The prevalence of NAFLD among patients with T2DM ranges from 59-70%, and T2DM significantly increases the risk of hepatic fibrosis and cirrhosis in these patients. Previous studies have shown that reducing liver fat significantly improves glycemic control in patients with T2DM. However, studies examining the effect of Dapagliflozin on liver fat in patients with T2DM are limited and have shown heterogeneous outcomes. Previous studies often had small sample sizes and short follow-up durations (3-4 months). The present study will be undertaken in patients with T2DM and NAFLD to evaluate the effect of Dapagliflozin over a period of 6 months on liver and body fat, and markers of insulin resistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients will be included only if they satisfy all the 3 inclusion criteria : 1-Type 2 Diabetes Mellitus patients aged more than 18 years and duration of diabetes less than 5 years.
- •2-Blood Glycated hemoglobin A1c(HbA1c) levels between 6.5% to 10%, on a stable dose of metformin and/or sulfonylureas over last 8 weeks.
- •3-Grade II or greater Fatty infiltration on abdominal ultrasound.
排除标准
- •1.Type 2 Diabetes Mellitus patients with poor glycemic control (Blood Glycated hemoglobin(HbA1c) more than 10%) or repeated history of Diabetic Ketoacidosis or Hyperglycemic Hyperosmolar State.
- •2.Patients requiring insulin due to ppor glycemic control or any serious illness.
- •3.Patients needing any rescue oral hypoglycemic therapy, other than metformin, sulfonylureas and dapagliflozin to achieve glycemic targets as per American Diabetes Association Guidelines.
- •4.Pregnant women, lactating women, women planning for pregnancy and gestational diabetes 5.Patients with estimated Glomerular Filteration rate less than 30 ml/min 6.Alcohol consumption more than 20 g per day for women or 30 g per day for men 7.Serology positive for HbSAg, HCV infection.
- •8.Serum ferritin more than 300ng/ml 9.Serum Ceruloplasmin less than 14ng/ml 10.Serum ANA positivity 11.Child-Pugh class B/C liver cirrhosis 12.Confounding concomitant drug use (including insulin, incretin mimetics, thiazolidinediones, vitamin E, UDCA).
结局指标
主要结局
1.To study the effect of Dapagliflozin 10 mg for 6 months, in patients of NAFLD with T2DM on liver fat signal fraction and fibrosis scores
时间窗: At baseline and at 6 months
2.To study the effect of Dapagliflozin 10 mg for 6 months, in patients of NAFLD with T2DM on body fat mass and anthropometric parameters
时间窗: At baseline and at 6 months
3.To study the effect of Dapagliflozin 10 mg for 6 months, in patients of NAFLD with T2DM on HOMA-IR and Adiponectin levels
时间窗: At baseline and at 6 months
次要结局
- Effect of Dapagliflozin 10 mg in patients of Type 2 Diabetes and Non-Alcoholic Fatty Liver Disease on HOMA-IR and serum Adiponectin levels
研究者
Bandana Dash
MKCGMCH