Efficacy of time restricted eating in patients of non alcoholic fatty liver disease: A chronophysiological interventional study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Improvement in insulin resistance as measured by Mean reduction in HOMA IR at 12 weeks.
研究概览
简要总结
Patients will be randomised in 2 groups, Group A will receive hypo-caloric diet calculated as 500 kcal deficit on basal energy expenditure and Group B will receive Hypocaloric diet with restriction of time of meals from 9 am to 6 pm. All patient will be advised exercise as per guidelines and will be followed weekly for 4 weeks followed by once a month. Patients will under go detailed history including life style details and eating behaviours along with anthropometric measurement.
All patients will be counselled by registered dietician as per above followup. Primary objective is to study mean improvement in HOMA IR at 12 weeks. secondary objective is to study changes in liver stiffness, steatosis measured by CAP ,changes in lipids, blood pressure, blood sugar ,weight, BMI and waist hip ratio. Based on previous studies we planned to enrol 76 patients with power of 80% and alpha error of 5%.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with NAFLD(defined by USG suggestive of steatosis with raised liver enzymes) between 18 yrs to 60 yrs.
排除标准
- •Patients with other liver diseases, diabetics, pregnancy and chronic systemic illness.
结局指标
主要结局
Improvement in insulin resistance as measured by Mean reduction in HOMA IR at 12 weeks.
时间窗: Improvement in insulin resistance as measured by Mean reduction in HOMA IR at 12 weeks.
次要结局
- Improvement in steatosis as measured by proportion of patients acheiving atleast one grade decrease in steatosis as per USG(Mean change in liver stiffness(LSM) at day 90 as measured by fibroscan)
研究者
Dr Ajay kumar Mishra
SGPGI lucknow