title: Metformin in obese children and adolescents: the MOCA trial.
abstract: BACKGROUND
  Childhood obesity is increasingly associated with type 2 diabetes (T2D). Metformin reduces the risk for T2D in adult obese nondiabetic patients, but the evidence in obese children and young people is inconclusive.
  
  
  OBJECTIVE
  The objective of the study was to assess the effect of metformin on body mass index sd score (BMI-SDS), metabolic risk factors, and adipokines.
  
  
  METHODS
  This was a prospective, randomized, double-blind, placebo-controlled trial.
  
  
  METHODS
  The study was conducted at six pediatric endocrine centers in the United Kingdom.
  
  
  METHODS
  One hundred fifty-one obese children and young people with hyperinsulinemia and/or impaired fasting glucose or impaired glucose tolerance (metformin: 74, placebo: 77). The study was comprised of 67.5% females, 65.6% postpubertal individuals, and 23.8% British Asian or Afro-Caribbean participants. The age range was 8-18 yr, the mean age was 13.7 (SD 2.3) yr, and the mean BMI-SDS was +3.4 (SD 0.5).
  
  
  METHODS
  The intervention included metformin 1 g in the morning and 500 mg in the evening vs. placebo for 6 months.
  
  
  METHODS
  The main outcome measure was a reduction in BMI-SDS at 6 months. Secondary outcomes included insulin and glucose levels from oral glucose tolerance tests, alanine aminotransferase (ALT), and adiponectin to leptin ratio (ALR) at 3 and 6 months.
  
  
  RESULTS
  Metformin was associated with a significant reduction in BMI-SDS compared with placebo at 6 months [mean difference -0.1 SD (95% confidence interval -0.18 to -0.02), P = 0.02]. Significant improvements at 3 months were found in the metformin group: fasting glucose, -0.16 mmol/liter (-0.31 to -0.00), P = 0.047; ALT, 19% (5-36%), P = 0.008; and ALR, 32% (4-67%), P = 0.02.
  
  
  CONCLUSIONS
  Metformin therapy has a beneficial treatment effect over placebo for BMI-SDS, fasting glucose, ALT, and ALR ratio at 3 months, with changes in BMI-SDS sustained at 6 months.
authors.affiliation: Department of Pediatric Endocrinology, Royal Manchester Children's Hospital, Oxford Road, Manchester M13 9WL, United Kingdom. drdlclough@hotmail.com
authors.forename: D
authors.initials: D
authors.lastname: Kendall
authors.forename: A
authors.initials: A
authors.lastname: Vail
authors.forename: R
authors.initials: R
authors.lastname: Amin
authors.forename: T
authors.initials: T
authors.lastname: Barrett
authors.forename: P
authors.initials: P
authors.lastname: Dimitri
authors.forename: F
authors.initials: F
authors.lastname: Ivison
authors.forename: M
authors.initials: M
authors.lastname: Kibirige
authors.forename: V
authors.initials: V
authors.lastname: Mathew
authors.forename: K
authors.initials: K
authors.lastname: Matyka
authors.forename: A
authors.initials: A
authors.lastname: McGovern
authors.forename: H
authors.initials: H
authors.lastname: Stirling
authors.forename: L
authors.initials: L
authors.lastname: Tetlow
authors.forename: J
authors.initials: J
authors.lastname: Wales
authors.forename: N
authors.initials: N
authors.lastname: Wright
authors.forename: P
authors.initials: P
authors.lastname: Clayton
authors.forename: C
authors.initials: C
authors.lastname: Hall
mesh_terms: D000293:Adolescent; D017668:Age of Onset; D002648:Child; D003924:Diabetes Mellitus, Type 2 / Q000209:etiology / Q000517:prevention & control; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008687:Metformin / Q000009:adverse effects / Q000627:therapeutic use*; D009765:Obesity / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology; D010919:Placebos; D016896:Treatment Outcome; D016903:Drug Monitoring
chemical_list: D007004:Hypoglycemic Agents; D010919:Placebos; D008687:Metformin