NCT02274948.

Trial name or title	Use of Metformin in Treatment of Childhood Obesity
Methods	Type of trial: interventional Allocation: randomised Intervention model: parallel assignment Masking: double blind (participant, carer, investigator, outcomes assessor) Primary purpose: treatment
Participants	Condition: paediatric obesity Enrolment: estimated 120 Inclusion criteria: obese children (based on > +2 SD of BMI to age on WHO 2007 standards) Exclusion criteria: children not of Sri Lankan origin children who are not planning to live in Sri Lanka during the next year children with a secondary underlying cause for the overweight/obesity
Interventions	Intervention: metformin Comparator: placebo
Outcomes	Primary outcomes: improvement in childhood obesity (time frame: 1 year) improvement of obesity will be measured by reduction in body fat content and BMI Secondary outcome: improvement in obesity‐related metabolic derangements including insulin resistance (time frame: 1 year) Other outcomes: none given
Starting date	Trial start date: July 2014 Trial completion date: February 2016
Contact information	Responsible party/principal investigator: Pujitha Wickramasinghe, University of Colombo
Study identifier	NCT number: NCT02274948
Official title	Effects of Metformin on Body Weight, Composition and Metabolic Derangements in Obese Children. A Randomized Clinical Trial
Stated purpose of study	This study expects to evaluate the use of metformin in the management of obese children. Insulin resistance among obese Sri Lankan children (south Asian origin) is high, which had been shown in the investigators previous work. This study will look at the effect of metformin on changes in insulin resistance, fatty liver state, body fat content, BMI and other metabolic derangement
Notes	Trial sponsored by University of Colombo; recruitment status when identified: this trial is currently recruiting participants; location: Sri Lanka