EUCTR2010‐023061‐21.

Trial name or title	Efectos de la metformina en la obesidad infantil: "Effects of metformin on childhood obesity"
Methods	Type of trial: interventional; randomised controlled trial Allocation: randomised Intervention model: parallel assignment Masking: double blind Primary purpose: treatment
Participants	Condition: obesity in prepubertal and pubertal children Enrolment: target 160 Inclusion criteria: obese children aged 7 to 14 years prepubertal and pubertal children, boys and girls, with exogenous obesity basic or history of disease pathology not received medical treatment or diet (or both) that would interfere with the analytical results 12 months before inclusion of the same participant more than once not permitted not participated in a previous trial Exclusion criteria: participants who do not meet the prescribed age submit or have submitted some underlying disease earlier receive or have received medication with metabolic adverse effects such as diuretics, beta‐blockers, beta‐adrenergic agonists, corticosteroids children undergoing long periods of rest
Interventions	Intervention: metformin Comparator: placebo
Outcomes	Primary outcome: BMI (baseline, weeks 8, 16 and 24) Secondary outcomes: blood pressure, blood analysis (lipid profile, hydrocarbon, inflammatory, oxidative) lifestyle survey (baseline, weeks 8, 16 and 24) Other outcomes: not given
Starting date	Trial start date: not given Trial completion date: not given
Contact information	Trial sponsor: Ramón Cañete Estrada Name of organisation: Instituto de Salud Carlos III Country: Spain Contact details: Avda Menendez Pidal s/n, Córdoba, 14004, Spain. Tel: 34957011227. Email: cetico.hrs.sspa@juntadeandalucia.es
Study identifier	EU clinical trials register number: EUCTR2010‐023061‐21
Official title	Original title: Ensayo clínico sobre efectos de la metformina en la obesidad pediátrica: efectos en el peso corporal, perfil de biomarcadores inflamatorios y de riesgo cardiovascular, e impacto en factores relacionados con el síndrome metabólico English title: Clinical trial on the effect of metformin in pediatric obesity: effects on bodyweight, profile and inflammatory biomarkers of cardiovascular risk, and impact on factors related to metabolic syndrome
Stated purpose of study	To study the clinical and biochemical impact of metformin along with changing lifestyle (diet and exercise) in obese children
Notes	Majority of this online entry is in Spanish; sponsor status: noncommercial; trial was ongoing when identified