To compare the weight loss Liver function tests blood pressure and quality of life in patients of metabolic syndrome and or NAFLD with and without Time restricted eating an open label interventional study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 193
- 试验地点
- 1
- 主要终点
- Liver function tests at baseline and at 12 weeks
研究概览
简要总结
This study will be an open label interventional study involving the diagnosed cases of metabolic syndrome or NAFLD meeting the defined inclusion and exclusion criteria and providing informed consent within one year of ethics committee approval
All the patients in the study will be divided into two groups Permuted block randomization will be done to avoid confounding and bias Baseline characteristics will be recorded before the intervention and follow up will be done at 0 and 3 months Both groups will be given routine standard of care a balanced diet vitamin E supplements and probiotics and exercise therapy per the clinician advice The test group will be advised time restricted eating for 14 to 16 hours by fixing a feeding window of 9 am to 7 pm to ensure 14 to 16 hours of fasting and gradually reducing the feeding window to reach 16 hours if tolerated BMI mean office BP liver function tests and lipid profile will be assessed at baseline after three months The questionnaire will evaluate the quality of life
This will be a study of 3 month duration and patient follow up will be done from 0 to 3 months Assessment of the efficacy parameters will be done at baseline and the end of the study The parameters measured will be systolic blood pressure and diastolic BP which will be measured when the patient arrives in OPD using the automated BP apparatus Three readings one minute apart will be taken and the mean of the last two readings will be calculated and recorded Liver function tests and lipid profiles will be obtained by taking blood samples QOL will be assessed using the WHO BREF questionnaire and scores will be recorded before and after three months Body weight in kg height in meters and waist and hip circumference will also be recorded.BMI will be calculated
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 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed case of metabolic syndrome and or Nonalcoholic fatty liver disease Age between 18 and 75 years Body mass index of greater than or equal to 25 kilogram per metre square.
排除标准
- •Pregnancy or lactation Inherited or acquired immunodeficiency On immunosuppressive drugs On insulin or insulin secretagogues Malignancies Mental illness Chronic kidney disease with estimated glomerular filtration rate eGFR less than or equal to30 Aspartate aminotransferase or Alanine transaminase more than three times the upper limit of normal.
结局指标
主要结局
Liver function tests at baseline and at 12 weeks
时间窗: Liver function tests at baseline and at 12 weeks
次要结局
- quality of life through a questionnaire of patients included in the study QOL will be assessed using the WHO BREF questionnaire.(At baseline and after 3 months)
- weight loss in terms of Body Mass Index(At baseline and after 3 months)
- mean blood pressure(At baseline and after 3 months)
- Fasting lipid profile(At baseline and after 3 months)
研究者
DR RIMPLE JEET KAUR
All India institute of medical sciences jodhpur