| Trial ID: | L0758 |
| Source ID: | CTRI/2018/03/012723
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| Associated Drug: |
Metformin
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| Title: |
Efficacy of metformin in reduction of hepatic fat fraction and insulin resistance in overweight adolescents with non-alcoholic fatty liver disease: an RCT
|
| Acronym: |
--
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| Status: |
Recruiting
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| Study Results: |
No Results Available
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| Results: |
--
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| Conditions: |
Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Health Condition 2: null- Obesity and non-alcoholic fatty liver disease
Health Condition 3: E660- Obesity due to excess calories
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| Interventions: |
Intervention1: Diet, lifestyle and metformin x 6 months: Healthy and balanced meals, with modest calorie reduction, intake of low GI carbohydrates, avoiding sugar sweetened beverages and processed food, and increasing fruit and vegetable intake. Detailed
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| Outcome Measures: |
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 randomizationChange 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
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| Sponsor/Collaborators: |
ICMR
|
| Gender: |
--
|
| Age: |
nannan
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| Phases: |
Not applicable
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| Enrollment: |
120
|
| Study Type: |
Interventional
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| Study Designs: |
Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry O
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| Start Date: |
21/03/2018
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
24 November 2021
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| Locations: |
India
|
| URL: |
http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=22947
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