Purpose: Obesity in adolescence increases the risk for early adult cardiovascular disease. We recently showed that 6 months of diet, exercise, and metformin resulted in reductions in adiposity and that diet/exercise alone reduced proinflammatory factors and intrahepatic fat in pubertal children with uncomplicated obesity. The purpose of the present study was to determine whether changes in cardiorespiratory fitness (CRF) after 6 months of structured diet and exercise (DE) or DE plus metformin are related to the previously observed changes in adiposity, markers of inflammation, and intrahepatic fat.
Methods: Sixteen obese pubertal adolescents between the ages of 10 and 17 were randomized into a structured lifestyle program consisting of DE or DE plus metformin. Subjects performed aerobic and resistance exercise 3 d·wk⁻¹, 30 min per session. Cycle ergometer maximal oxygen consumption (V˙O2max), body composition, blood markers (glucose, insulin, homeostatic model assessment-insulin resistance, interleukin-6, hsCRP), and intrahepatic fat were measured at baseline and 6 months.
Results: In the cohort, as whole-body weight decreased by 4.0% (P = 0.009), body mass index decreased by 4.9% (P = 0.003), percent body fat decreased by 8.8% (P < 0.001), and V˙O2max improved in 10 of 16 subjects. The addition of metformin provided no further effect on body composition, CRF, or inflammatory factors. More favorable changes in adiposity, adiponectin, and a trend toward blood glucose and interleukin-6 concentrations (P = 0.07) were observed in subjects who increased V˙O2max at 6 months (n = 10) compared with no change in these variables in those who did not improve V˙O2max.
Conclusions: Metformin did not provide benefits above lifestyle modification for improving CRF in obese adolescents. Improvements in V˙O2max seem to be associated with more favorable metabolic outcomes.
Trial registration: ClinicalTrials.gov NCT00139477.