RT Journal Article
T1 Evaluation of differential effects of metformin treatment in obese children according to pubertal stage and genetic variations: study protocol for a randomized controlled trial.
A1 Pastor-Villaescusa, Belén
A1 Caballero-Villarraso, Javier
A1 Cañete, M Dolores
A1 Hoyos, Raúl
A1 Maldonado, José
A1 Bueno, Gloria
A1 Leis, Rosaura
A1 Gil, Ángel
A1 Cañete, Ramón
A1 Aguilera, Concepción M
K1 Metformin
K1 Children
K1 Obesity
K1 Puberty
K1 Lifestyle intervention
K1 Microbiota
K1 Polymorphisms
K1 Niño
K1 Método doble ciego
K1 Dislipidemias
K1 Variación genética
K1 Hipoglucemiantes
K1 Inflamación
K1 Resistencia a la insulina
K1 Síndrome X metabólico
K1 Metformina
K1 Obesidad
K1 Farmacogenética
K1 Estudios prospectivos
K1 Pubertad
K1 Salud pública
K1 Distribución aleatoria
K1 Indice de masa corporal
AB BACKGROUNDOverweight and obesity are considered to be serious public health problems. In pediatric populations, insulin resistance, dyslipidemia, and hypertension associated with obesity occur with increased frequencies. Metformin is an oral anti-hyperglycemic agent that has been demonstrated to be efficacious in the treatment of diabetic and non-diabetic obese adults. A considerable amount of pharmacogenetic research has demonstrated that genetic variation is one of the major factors affecting metformin response. Additionally, potential microbiota-mediated mechanisms of metformin effect have been recently described. However, scant work has been conducted in children, with no attention being paid to the potential effects of pubertal development. Thus, the main objective of the present study is to evaluate the effect of metformin treatment together with lifestyle recommendations in a randomized control trial (RCT) of obese children according to pubertal stage, genetic variants and signature of gut microbiota.METHODS/DESIGNThis is a randomized, prospective, double-blind, placebo-controlled, multicenter trial, which is stratified by puberty and sex. Eighty pre-pubertal (40 boys and 40 girls) and 80 pubertal non-diabetic obese children (40 boys and 40 girls) are being recruited in four Spanish Clinical Hospitals. The inclusion criteria to participate in the RCT include a Body Mass Index (BMI) above the 95th percentile and age 7-14 years. The pubertal stage is determined based on the Tanner criteria. Participants are assigned to two groups in accordance with a randomization schedule and receive 1 g of metformin or placebo for six months in combination with healthy lifestyle recommendations in both groups. The primary outcomes include changes in the BMI Z score and the biomarkers associated with the early appearance of insulin resistance syndrome, inflammation, cardiovascular risk according of the presence of genetic determinants of metformin response, as well as possible modifications in microbiota.DISCUSSIONThis study will assess the differential response of metformin treatment at six months in pre-pubertal and pubertal obese children.TRIAL REGISTRATIONRegistered by European Clinical Trials Database (EudraCT, ID: 2010-023061-21) on 14 November 2011.
PB BioMed Central
YR 2016
FD 2016-07-18
LK http://hdl.handle.net/10668/2321
UL http://hdl.handle.net/10668/2321
LA en
NO Pastor-Villaescusa B, Caballero-Villarraso J, Cañete MD, Hoyos R, Maldonado J, Bueno G, et al. Evaluation of differential effects of metformin treatment in obese children according to pubertal stage and genetic variations: study protocol for a randomized controlled trial. Trials. 2016; 17(1):323
NO Journal Article; TRIAL REGISTRATION:Registered by European Clinical Trials Database (EudraCT, ID: 2010-023061-21) on 14 November 2011
DS RISalud
RD Apr 10, 2025