Double-blind Randomized Placebo-controlled Clinical Trial of Omega 3 Fatty Acids for the Treatment of Diabetic Patients With Nonalcoholic Steatohepatitis

Study answer

What this study found

Omega-3 PUFA did not improve NASH histology or insulin resistance versus placebo, and the overall conclusion was that PUFA supplementation was not beneficial in diabetic patients with NASH. In the PUFA arm, NAFLD activity score changed from 6.12 ± 0.99 to 5.41 ± 1.20, but histologic components did not show significant favorable change. Fasting glucose increased from 129.9 ± 36.5 to 150.4 ± 43.7 and HOMA-IR from 12.0 ± 6.8 to 16.1 ± 10.3, while AST fell from 47.7 ± 22.8 to 41.7 ± 17.4 and ALT from 60.1 ± 27.6 to 56.9 ± 30.9 without a meaningful clinical benefit. The intervention was well…

Study & population

Double-blind, randomized, placebo-controlled trial in adults with type 2 diabetes and biopsy-confirmed nonalcoholic steatohepatitis.

Intervention

Oral omega-3 fatty acid capsules containing 2160 mg EPA plus 1440 mg DHA per day, given in 2 divided doses for 48 weeks.

Key limitation

The active intervention group was small, and the trial lasted only 48 weeks.

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Original abstract