Background: Insulin resistance precedes metabolic syndrome abnormalities, and may promote cardiovascular disease and type 2 diabetes in obese children. Lifestyle modification programs have been proposed as the gold standard of care in these individuals. However, results have been discouraging and the use of adjuvant strategies has been necessary. Metformin has beneficial effects on weight reduction, favoring a decrease in body mass index (BMI) and insulin resistance in obese non-diabetic individuals. Furthermore, several studies have acknowledged the beneficial effects of CLA isomers on body composition, insulin sensitivity and lipid metabolism in experimental animals and humans.
Objective and hypotheses: Evaluate metformin and Conjugated Linoleic Acid (CLA) effects on insulin sensitivity, measured by the gold standard Euglycemic-Hyperinsulinemic Clamp Technique, in obese Mexican children. We hypothesized that Metformin and CLA would exceed lifestyle intervention benefit with an effect size of at least 30% over the main outcome M-value insulin sensitivity compared to placebo treated patients
Method: A randomized, double-blinded 16-weeks placebo-controlled clinical trial was conducted. Obese children and adolescents were randomly assigned to receive either metformin (1 g), CLA (3 g) or placebo. (Clinicaltrials.gov:NCT02063802).All patients were included in s standardized lifestyle intervention programe
Results: Intervention had a positive effect on weight, height, BMI, waist circumference and fitness condition in all groups. For the primary outcome, Insulin Sensitivity M-value (mg/kg/min), there was a statistically significant difference between CLA group compared to PLB (6.53±2.54 Vs 5.05±1.46, P=0.035). Fasting insulinemia and HOMA-IR significantly improved in CLA group (P=0.045). Covariance analyses were executed to control the influence of BMI, Δ-BMI, age, Tanner stage, prescribed diet and fitness achievement over the Insulin Sensitivity M-value. Tanner stage showed statistical significant influence.
Conclusion: A clinically relevant effect size on insulin sensitivity was evident in CLA treated patients (37%) that exceed lifestyle intervention program benefits.
10 - 12 Sep 2016
European Society for Paediatric Endocrinology