跳至主要内容
临床试验/CTRI/2022/04/042201
CTRI/2022/04/042201招募中不适用

A study of association of Metabolic Dysfunction Associated Fatty Liver Disease (MAFLD) and dynapenia/sarcopenia with cardio-metabolic risks

ICMR1 个研究点 分布在 1 个国家目标入组 1,100 人开始时间: 2022年5月16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
1,100
试验地点
1
主要终点
ASCVD risk score, Prevalence of dynapenia and sarcopenia in

研究概览

简要总结

Background: The presence of sarcopenia is regarded as an important indicator of theseverity and prognosis of NAFLD, which might be extrapolated into MAFLD because ofits substantial overlap with NAFLD. The severity of NAFLD is associated with ASCVDrisk, independently of other cardiovascular risk factors. Based on these prognosticimplications of liver fibrosis and ASCVD in patients with NALFD, the severities of thesetwo factors might also differ among subgroups of patients according to MAFLD severity.• Novelty: The study will examine the association of dynapenia/sarcopenia in MAFLDwith cardio-metabolic risks which is the first study in India.• Objectives: To assess the association of Metabolic Dysfunction Associated Fatty LiverDisease (MAFLD) and dynapenia/sarcopenia with cardio-metabolic risks. Anotherobjective is to assess the prevalence of dynapenia and sarcopenia in subjects with MAFLD,to assess the association of liver fibrosis and steatosis in subjects with dynapenia andsarcopenia in MAFLD through non-invasive methods (FIB4, NFS and Fibroscan) and toassess the risk of dynapenia and sarcopenia in subjects with MAFLD and its associationwith various lifestyle, anthropometric and biochemical factors.• Methods: The study is observational with cross-sectional study design. Subjects attendingMedicine OPD will be screened for MAFLD, followed by Dynapenia/Sarcopenia.• Expected outcome: There will be significant association between MAFLD, Dynapenia orsarcopenia and ASCVD. The risk of ASCVD may be higher in subjects having bothMAFLD and dynapenia/sarcopenia.

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

  • Adults of age 18-60 years, with fatty liver disease Obese/Overweight individuals Type 2 Diabetes Mellitus Metabolically dysregulated Lean body individuals Hand grip strength Men <28 kg, Women <18 kg Appendicular skeletal muscle mass/height2 : Men<7.0kg/m2, Women <5.4 kg/m
  • SPPB≤8 (The maximum score on the SPPB is:12) 4-minute gait speed <0.8m/s.

排除标准

  • Pregnant women Patient denying consent Cirrhotic liver disease patients Pediatric population.

结局指标

主要结局

ASCVD risk score, Prevalence of dynapenia and sarcopenia in

时间窗: one time study

MAFLD subjects.

时间窗: one time study

• metabolic parameters, insulin resistance and subclinical

时间窗: one time study

inflammation

时间窗: one time study

次要结局

  • metabolic parameters, insulin resistance and subclinical(inflammation)

研究者

发起方
ICMR
申办方类型
Government funding agency

研究点 (1)

Loading locations...

相似试验