Outcomes
INSULIN RESISTANCE, INSULIN SENSITIVITY
The primary outcome was a change in anthropometric measurements and glucose, insulin and lipid concentrations, as well as variations in insulin release, insulin resistance, and insulin sensitivity. Secondary outcomes were variation in serum creatinine, uric acid, hepatic enzymes and change in blood pressure. The change (variation) was the difference obtained between baseline and the end of treatment (6 months).Another primary outcome was variation in the biochemical measurements, as well as differences in insulin release, insulin resistance and insulin sensitivity between the ERs and ENRs for each treatment group (Obex® and placebo), in addition to the change obtained between baseline and 6 months of treatment in the ERs and ENRs in each treatment group among subjects who completed the trial.