Metformin for NAFLD in adolescents
- Conditions
- Health Condition 1: K760- Fatty (change of) liver, not elsewhere classifiedHealth Condition 2: null- Obesity and non-alcoholic fatty liver diseaseHealth Condition 3: E660- Obesity due to excess calories
- Registration Number
- CTRI/2018/03/012723
- Lead Sponsor
- ICMR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 140
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in hepatic fat fraction (HFF, measured by MRI) from baseline. A relative reduction of 40% from the baseline HFF will be considered as significant. Thus, if baseline HFF is 25%, reduction to 15% at 6 months (reduction by 10%, which is 40% of 25), will be considered significant. <br/ ><br>The proportion that achieves a significant reduction in HFF, will be compared in both arms using chi-square test. The mean change in HFF will also be compared in both arms using student’s t-test. <br/ ><br>Timepoint: At 6 months from the time of randomization
- Secondary Outcome Measures
Name Time Method Change in BMI, body fat percentage, waist circumference, serum fasting insulin, HOMA-IR, HbA1c, ALT and liver acoustic radiation force impulse (ARFI) elastography from baseline will be compared in both arms.Timepoint: At 6 mo from the time of randomization