When used as treatment for obese children with hyperinsulinemia and/or impaired fasting glucose or impaired glucose tolerance, researchers in the UK found that metformin was also linked to a significant reduction in BMI compared with placebo.
In the Metformin in Obese Children and Adolescents (MOCA) trial, researchers aimed to discover whether metformin 1.5 g per day for 6 months in obese children and adolescents (aged 8 to 18 years) with hyperinsulinemia and/or IFG or IGT was more effective compared with placebo in BMI standard deviation scores (BMI-SDS). The double blind, placebo-controlled, parallel-group trial took place in six pediatric endocrine centers in the UK.
The researchers also measured secondary outcomes of insulin and glucose levels from oral glucose tolerance tests, alanine aminotransferase (ALT) and adiponectin-to-leptin ratio (ALR) at 3 and 6 month intervals.
"The MOCA trial provides evidence that a short treatment course of metformin is clinically useful, safe, and well-tolerated to halt further gain in adiposity and improve fasting glucose, ALT, and ALR," the researchers wrote.
According to data, independent pharmacies dispersed metformin (1 g in the morning and 500 mg at night) or placebo for 6 months based on a computer-generated randomization list for each age group (males aged 8-13 years; females aged 8-13 years; males aged 14-18 years; and females aged 14-18 years).
The patients included 151 obese children and adolescents (67.5% female) with an average age of 13.7 years and mean BMI-SDS of 3.4. They were assigned to either placebo (n=77) or metformin (n=74).
Data indicate that metformin was linked to a significant reduction in BMI, from 37.1 kg/m2 at baseline to 36.56 kg/m2 at 3 months, compared with placebo (P=.004). This was also the case at 6 months (–0.1; 95% CI, –0.18 to –0.02), according to data.
Additional improvements were found in the metformin group at 3 months, including fasting glucose (–0.16 mmol/L; 95% CI, –0.31 to –0.00); ALT (19%; 95% CI, 5-36); and ALR (32%; 95% CI, 4-67).
No serious adverse events were reported, the researchers wrote. The most common were diarrhea, nausea and abdominal pain. Adherence to therapy was reportedly good among all patients, they added.