XXXX in the treatment of @entity1 with diabetes mellitus and @entity5881 . Efficacy study of a new preparation of an anti-oxidant agent.

@entity1 @entity2175 @entity70997 @entity5881 @entity1865 @entity1674 @entity409 @entity1234 @entity412 @entity413 @entity165
BACKGROUND AND AIMS: In @entity1 with @entity2175 (T2DM) and associated @entity409 , plasma levels of @entity413 , insulin and @entity1674 are high, lipid peroxidation is increased and natural antioxidant reserves are reduced. Thus, we hypothesised that the re-balancing of cell redox levels and amelioration of liver function could result in a better @entity413 and lipid metabolism. To study this, we assessed the effect of a new oral formulation of an antioxidant agent - @entity70997 (named IBI/S) - in @entity1 with chronic @entity5881 and concomitant T2DM. METHODS: Sixty outpatients were enrolled in a three-centre, double blind, randomised, IBI/S vs placebo study. Forty-two (21 in the group IBI/S - 135 mg/d silybin per os - and 21 in the placebo group) concluded the 6-month treatment period. The efficacy parameters included fasting and mean daily plasma @entity413 levels, glycosylated hemoglobin (HbA1c), basal, stimulated C-peptide and insulin levels, total-, HDL- @entity165 and @entity1674 levels in addition to conventional liver function tests. Insulin sensitivity was estimated by HOMA-IR. @entity1234 ( @entity1865 ) was also measured before and after treatment as an index of oxidative stress. RESULTS: Fasting blood @entity413 levels, which were similar at baseline in IBI/S group and in the placebo group (173.9 mg/dl and 177.1 mg/dl, respectively), decreased to 148.4 mg/dl (-14.7% vs baseline; p = 0.03) in the IBI/S group while they were virtually unchanged in the placebo group. The comparison between the groups at mo 6 (T6) also showed a significant reduction of @entity413 levels in the IBI/S group (p = 0.03). The same trend was observed in mean daily blood @entity413 levels, HbA1c and HOMA-IR, although differences were not significant. Basal and stimulated C-peptide values showed that only a few changes had occured in both groups. Such results indicate that insulin secretion was virtually unaffected, as confirmed also by the insulinemia data. Plasma @entity1674 concentrations dropped from a baseline value of 186 mg/dl to 111 mg/dl (T6) in the IBI/S group, with significant differences at all instances with respect to baseline values. By contrast, @entity1674 increased from 159 mg/dl at entry to 185 mg/dl (T6) in the placebo group. The difference between the groups at T6 was highly significant (p < 0.01). Total and HDL @entity165 as well as liver function tests did not change significantly during the study in both groups. @entity1865 decreased significantly only in the group receiving IBI/S. No clinically relevant side effects were observed in either group. CONCLUSIONS: Oral administration @entity70997 in @entity1 with T2DM and compensated chronic @entity5881 causes a significant decrease in both @entity413 and @entity412 plasma levels. These effects may be due to the recovery of energy substrates, consistent with a reduced lipid peroxidation and an improved insulin activity.
