BSPED2012 Oral Communications Oral Communications 4 (5 abstracts)
1Manchester Childrens Hospital, Manchester, UK; 2Birmingham Childrens Hospital, Birmingham, UK; 3Sheffield Childrens Hospital, Sheffield, UK; 4The James Cook University Hospital, Middlesborough, UK; 5Hull Royal Infirmary, Hull, UK; 6University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK; 7Salford Royal NHS Foundation Trust, Manchester, UK; 8Manchester Academic Health Sciences Centre, Manchester, UK; 9The University of Sheffield, Sheffield, UK.
Background: Childhood obesity is increasingly associated with type 2 diabetes (T2D). Metformin reduces the risk for T2D in adult obese non-diabetic patients, but the evidence in obese children and young people (CYP) is inconclusive.
Design: The metformin in obese children and adolescents (MOCA) trial was a prospective, multi-centre, randomized, double-blind, placebo-controlled trial of 1.5 g metformin daily in CYP with raised fasting or post-prandial insulin or glucose.
Aim: The primary objective was to assess the effects of metformin on body composition (primary outcome BMISDS at 6 months), metabolic risk factors and adipokines.
Methods: Auxology, arterial blood pressure measurement and fasting blood tests (insulin, glucose, fasting lipids, liver function, hs-CRP, lactate, resistin, adiponectin and leptin) were performed at baseline, 3 and 6 months with a prolonged oral glucose tolerance test at baseline and 6 months.
Participants: One hundred and fifty-one obese CYP participated in the trial (metformin: 74, placebo: 77). 67.5% were female, 65.6% post-pubertal, 23.8% British Asian or Afro-Caribbean. Age range 818 years, mean age 13.7 (S.D. 2.3) years and mean BMISDS 3.4 (0.5).
Results: Metformin was associated with a significant reduction in BMISDS compared to placebo at 6 months (mean difference: 0.1 S.D. (95% confidence interval 0.020.19), P=0.01,). Fasting glucose (0.16 mmol/l (00.33), P=0.05, and adiponectin/leptin ratio (ALR) (0.27 (−0.52 to −0.02), P=0.03) significantly improved at 3 months in the metformin group, but the changes were lost at 6 months. No significant changes were found in the other secondary outcomes.
Conclusion: Metformin therapy has a beneficial treatment effect over placebo for BMISDS, fasting glucose and ALR ratio at 3 months, with changes in body composition sustained at 6 months. MOCA is the largest study of its kind to date, and indicates that metformin is clinically useful, safe and well tolerated in obese CYP.