Clinical trial: insulin-sensitizing agents may reduce consequences of insulin resistance in individuals with non-alcoholic steatohepatitis.
BACKGROUND
Currently, although only a few therapies normalize the liver test abnormalities with/without improving the liver histology, no pharmacologic therapy has proved to be effective for the treatment of non-alcoholic steatohepatitis.


OBJECTIVE
To investigate the role of insulin sensitizers in the treatment of individuals with non-alcoholic steatohepatitis (NASH).


METHODS
A total of 74 individuals with NASH (male/female, 44/30; mean age, 47.2 +/- 9.0 years) were enrolled. Participants were divided into two distinct groups: group 1 (n = 25) participants were administered a conventional diet and exercise programme while those in group 2 (n = 49) were administered the diet and exercise programme plus insulin sensitizers.


RESULTS
With respect to baseline metabolic, biochemical and histological parameters, no significant differences were observed between the two groups (P > 0.05). Insulin sensitizers significantly improved metabolic parameters (homeostasis model assessment-insulin resistance score, P < 0.05), serum aminotransferase levels [aspartate aminotransferase (AST): 45.9 +/- 24.2 to 33.3 +/- 17.7 IU/L, P < 0.01; alanine aminotransferase (ALT): 78.2 +/- 46.3 to 47.3 +/- 34.5 IU/L, P < 0.001] and histological features (median non-alcoholic fatty liver disease activity score: 5.0-3.0, P = 0.01), while diet and exercise improved serum aminotransferase levels (AST: 39.3 +/- 11.1 to 30.0 +/- 8.6 IU/L, P < 0.01; ALT: 66.9 +/- 28.9 to 42.0 +/- 16.2 IU/L, P < 0.001) at the end of the 48 weeks when compared to baseline. Insulin sensitizers improved the high-sensitivity C-reactive protein levels (P < 0.01). No serious adverse effects of insulin sensitizers were observed.


CONCLUSIONS
Insulin sensitizers can lead to improvement in metabolic, biochemical and histological abnormalities of NASH as a result of improved insulin sensitivity.
Idilman
R
R
Department of Gastroenterology, Ankara University Faculty of Medicine, Ankara, Turkey. idilman@dialup.ankara.edu.tr
Mizrak
D
D
Corapcioglu
D
D
Bektas
M
M
Doganay
B
B
Sayki
M
M
Coban
S
S
Erden
E
E
Soykan
I
I
Emral
R
R
Uysal
A R
AR
Ozden
A
A
D000328:Adult; D000410:Alanine Transaminase / Q000097:blood / Q000378:metabolism*; D001219:Aspartate Aminotransferases / Q000097:blood / Q000378:metabolism*; D004035:Diet Therapy; D005081:Exercise Therapy; D005234:Fatty Liver / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007333:Insulin Resistance; D008297:Male; D008687:Metformin / Q000627:therapeutic use; D008875:Middle Aged; D000077154:Rosiglitazone; D045162:Thiazolidinediones / Q000627:therapeutic use; D016896:Treatment Outcome
D007004:Hypoglycemic Agents; D045162:Thiazolidinediones; D000077154:Rosiglitazone; D008687:Metformin; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase