Association of Adipose-Muscle Phenotypes with Clinical and Metabolic Parameters in Adult Patients with Metabolic-Associated Steatotic Liver Disease (MASLD)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- ICMR
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- identification of significant associations between Adipose-Muscle Phenotypes characterized by variations in visceral fat and lean mass and clinical and metabolic parameters in MASLD patients
研究概览
简要总结
Rationale: MASLD is a growing global health concern, strongly linked to obesity, insulin resistance, and systemic inflammation. However, obesity is a heterogeneous condition, and patients with similar BMI may exhibit varying fat distribution and muscle mass, influencing MASLD progression. Current diagnostic criteria overlook these variations, leading to misclassification of disease risk and suboptimal management strategies. Understanding these differences is crucial for improving disease assessment and therapeutic interventions.
Novelty: This study investigates distinct Adipose-Muscle Phenotypes in MASLD patients, an under-explored area. Unlike traditional BMI-based classifications, it emphasizes visceral fat, lean mass, and their interplay in disease progression. It integrates muscle strength, sleep quality, eating behavior, and physical activity to provide a comprehensive metabolic health assessment. This approach could redefine risk stratification and therapeutic strategies for MASLD.
Objectives: The objective is to examine the association between Adipose-Muscle Phenotypes, categorized based on visceral fat and lean mass levels, clinical and metabolic parameters in MASLD patients. The study also aims to compare muscle strength, quality of life, sleep quality, eating behavior, physical activity across these phenotypes.
Methods: This cross-sectional observational study will recruit 400 MASLD patients (100 each group) at AIIMS, New Delhi. Body composition will be assessed using BIA scan, liver steatosis and fibrosis will be evaluated through FibroScan. Biochemical markers, muscle strength, and quality of life will also be analysed.
Expected Outcome: The study aims to establish associations between Adipose-Muscle Phenotypes and clinical/metabolic parameters in MASLD. Findings could enhance patient stratification and guide personalized treatment strategies, improving long-term metabolic and hepatic outcomes.
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 MASLD, Willing to give informed consent, BMI above 18.5.
排除标准
- •Known case or recently diagnosed diabetes mellitus, Participants who have undergone any recent major surgery in the last three months, Any acute or chronic infectious illness, History of pancreatitis or any other diseases requiring dietary modifications or restrictions, Chronic liver, heart and kidney disease, osteoarthritis and advanced end organ damage, Pregnant and lactating women, Presence of seropositivity for Hepatitis B, C and Human Immunodeficiency Virus, Excessive alcohol use more than 20 g per day for women and more than 30 g per day for men, Intake of any anti obesity drugs like orlistat, liraglutide, etc.
- •currently or in the last three months.
结局指标
主要结局
identification of significant associations between Adipose-Muscle Phenotypes characterized by variations in visceral fat and lean mass and clinical and metabolic parameters in MASLD patients
时间窗: One time study
次要结局
- identification of a significant association between adipose- phenotypes characterized by variation in visceral fat and lean mass - and muscle strength, eating behaviour, sleep quality, and physical activity(One Time study)
研究者
Prof NAVAL KISHORE VIKRAM
AIIMS, New Delhi