CTRI/2018/03/012723已完成未知
Efficacy of metformin in reduction of hepatic fat fraction and insulin resistance in overweight adolescents with non-alcoholic fatty liver disease: an RCT
ICMR0 个研究点目标入组 140 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Overweight/ obese (BMI > centile equivalent to adult BMI of 23 using IAP 2015 BMI charts)
- •-Mild or moderate NAFLD (diagnosed by USG, and confirmed by MRI as having hepatic fat fraction > 5%)
- •-Resident of Delhi/ NCR and willing for regular follow-up
排除标准
- •1. Patients with hepatic fat fraction > 40% will be excluded and referred to pediatric gastroenterologist for further management
- •2.Adolescents with past history of jaundice or presence of any of the five features of hepatic insufficiency listed below will be excluded from the study: Serum bilirubin > 2 mg/dL, serum albumin < 3.5 mg/dL, PT INR > 1.7, ascites, hepatic encephalopathy
- •3. Those with any of the severe co-morbidities of obesity requiring pharmacological therapy of any type
- •4. Those with syndromic/ pathological/ monogenic/ endocrine illness associated obesity
- •5.Those with deranged renal function test
- •6. Secondary exclusion: Subjects with fatty liver on USG will be tested for HBsAg, anti-HCV antibodies and serum ceruloplasmin to rule out other etiologies for fatty liver, and excluded if these investigations are suggestive.
- •7. Secondary exclusion: LFT will be monitored in all subjects 2 monthly, those with > 20% rise in ALT or AST will be excluded.
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