跳至主要内容
临床试验/CTRI/2022/11/047422
CTRI/2022/11/047422招募中不适用

Association between different obesity phenotypes, liver steatosis and fibrosis and metabolic health in adult patients with Non-alcoholic fatty liver disease

AIIMS New Delhi1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2022年1月12日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
1
主要终点
Liver steatosis, liver fibrosis, biochemical and metabolic parameters (lipid profile, liver health markers and anthropometric parameters)

研究概览

简要总结

Non-alcoholic fatty liver disease (NAFLD) represents a major global healthcare challenge in the twenty first century. NAFLD has emerged as one of the leading causes of cirrhosis, hepatocellular carcinoma and liver transplant in India.Prevalence of the disease is estimated to be around 9-32% in the general Indian population, with a higher incidence rate amongst obese and diabetic patients. Researchers have suggested that NAFLD can be regarded as hepatic manifestation of metabolic syndrome. Overweight and obesity are the main drivers of metabolic disease and NAFLD. Nevertheless, not all obese are metabolically unhealthy, neither all normal weight /lean are metabolically healthy. Being normal weight with metabolic abnormalities was also associated with risk of NAFLD. The link between NAFLD and metabolic syndrome is more complex that previously thought. Indeed the metabolic syndrome shows mutual and bi-directional associations with NAFLD such that NAFLD is now considered to be both a cause and consequence of metabolic syndrome. Future research is required to better understand the association between NAFLD, obesity phenotypes and metabolic syndrome. So, The present study will aim to find the association between NAFLD and different obesity phenotypes (Metabolically healthy non obese (MHNO), Metabolically healthy obese (MHO), Metabolically unhealthy non obese (MUNO), Metabolically unhealthy obese (MUO) among study population.

This will be a cross sectional observational study, all the patients attending Out Patient Department (OPD) of Tertiary Care Hospital in Delhi will be screened for inclusion and exclusion criteria. Both male and female aged between 18-60 years and are diagnosed with fatty liver with a BMI above 18.5 kg/m2 will be recruited in the study and the patients diagnosed with diabetes mellitus, have any end organ damage, or have any history of pancreatitis will be excluded from the study. Approval from Institutional Ethical Committee (IEC) from Lady Irwin college and tertiary care hospital will be obtained before conducting the study. A written consent will be obtained and study information sheet will be given to each participant. Different tools and techniques will be used for data collection. All the participants will undergo fibroscan analysis for NAFLD diagnosis, clinical, anthropometry, biochemical and dietary data will also be obtained. Proir to data collection, pilot testing of all the tools will be done. All the data obtained through questionnaire, anthropometric measurement and dietary intake will be cleaned, coded and computerized using Microsoft Excel 2007 and SPSS software (version 24.0). Missing data will be checked to prevent errors. The qualitative data will be treated to obtain frequencies and percentages. Mean, median, standard deviation and range will be obtained using quantitative data. Karl pearson’s correlation test will be used to find association between different variables. Dietary data will entered in Diet Cal software and will be compared with the recommendations given by ICMR.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Age 18-60 years Diagnosed with non- alcoholic fatty liver disease BMI above 18.5 kg/m2.

排除标准

  • Known case or recently diagnosed diabetes mellitus Acute infection and advanced end organ damage History of pancreatitis Participants undergone any recent surgery On any medication within last one month which could potentially influence insulin secretion, insulin sensitivity Pregnancy and lactation at the time of study.
  • Chronic heart disease and chronic kidney disease Acute and chronic hepatitis Excessive alcohol use (>20 g a day for women and >30 g for men).

结局指标

主要结局

Liver steatosis, liver fibrosis, biochemical and metabolic parameters (lipid profile, liver health markers and anthropometric parameters)

时间窗: One Time (At baseline only)

次要结局

  • ASCVD risk score, FIB-4 Score, NFS Score, Muscle strength, quality of life and sleep quality(One Time (At Baseline only))

研究者

发起方
AIIMS New Delhi
申办方类型
Government medical college

研究点 (1)

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