Effects of rosiglitazone on body fat distribution and insulin sensitivity in Korean type 2 diabetes mellitus patients.

The objective of the study was to investigate the effects of rosiglitazone (RSG), a thiazolidinedione derivative, on body fat distribution and insulin sensitivity in Korean subjects with type 2 diabetes mellitus. This study was a phase IV, multicenter, single-blind, positive-controlled parallel group study. Eighty-nine patients with type 2 diabetes mellitus, aged 30 to 75 years, were enrolled in this study. Their fasting plasma glucose levels ranged from 126 to 270 mg/dL, and subjects had hemoglobin A1c levels of greater than 7.0%. We compared the effect of the treatment with glibenclamide plus RSG 4 mg/d (increased to 8 mg/d after 6 months) with glibenclamide plus placebo on body fat distributions, which were determined by computed tomography scanning and glycemic and insulinemic responses to oral glucose load. During the 12-month treatment period, the difference between the changes in the ratio of the intraabdominal adipose tissue (IAAT) to abdominal subcutaneous adipose tissue areas (SAT) between treatment groups was significant (from 1.13 +/- 0.53 to 1.00 +/- 0.40 in the RSG group and from 0.92 +/- 0.54 to 0.96 +/- 0.62 in the placebo group, P = .0351). The glycemic responses to oral glucose load (area under the curve, millimoles per liter per hour) were improved in the RSG group with 12 months of treatment (from 4.88 +/- 1.10 to 4.38 +/- 1.35 in 1 hour and from 13.78 +/- 2.83 to 12.16 +/- 2.52 in 2 hours), and the difference between the changes of the glycemic response showed statistical significance between groups (RSG group vs placebo group: -0.53 +/- 1.42 vs 0.38 +/- 1.31, difference in 1 hour; -0.76 +/- 2.98 vs 1.43 +/- 2.58, difference in 2 hours). However, there was no difference between insulin responses from baseline to follow-up and no differences in the change in insulin response between groups. In Korean subjects with type 2 diabetes mellitus, 12 months of treatment with RSG may increase SAT, but may have a neutral effect on IAAT, resulting in a decrease in the IAAT:SAT ratio. The RSG treatment improved the glucose control in type 2 diabetes mellitus. However, it is important to determine whether the glucose-lowering effect of RSG occurs mainly through direct enhancement of insulin sensitivity.

RCT Entities:   Population Interventions Outcomes