Breakthrough for Fatty Liver Disease?

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Could bile acids play a role in reducing metabolic syndrome and in particular fatty liver disease?  This question is now being studied (Gastroenterology 2013; 145: 574-82).

This recent study examined whether obeticholic acid (OCA) which is a semisynthetic derivative of the human bile acid chenodeoxycholic acid could aid with insulin resistance and ultimately nonalcoholic fatty liver disease (NAFLD).  OCA is an agonist of the farnesoid X receptor which is a nuclear hormone receptor that regulates glucose and lipid metabolism.

The authors performed a phase 2, double-blind, placebo-controlled study to assess the effects of OCA on insulin sensitivity in patients with NAFLD and type 2 diabetes mellitus.  Patients received either placebo (n=23), 25 mg OCA (n=20), or 50 mg OCA (n=21) once daily for 6 weeks.  Using an insulin clamp, insulin sensitivity was measured before and after the study period.  Numerous blood tests were obtained as well.

Results:

  • Insulin sensitivity improved 28% in the 25mg OCA group and 20.1% in the 50 mg OCA group whereas it decreased 5.5% in the placebo group.
  • The OCA groups also had significant reductions in gamma-glutamyltransferase, alanine aminotransferase, and dose-related weight loss.
  • Markers of liver fibrosis decreased in the 25 mg OCA group.
  • Side effects of OCA were minimal.  Constipation was reported in the 50 mg OCA group.

Take-home message: OCA may help patients with NAFLD and a bigger, longer study is in the works (FLINT study: 25 mg OCA for 72 weeks compared with placebo, http://www.clinicaltrials.gov; NCT01265498)

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