Evidence map›Paper›PMID 27432166›Full record

Trial reportTrials2016

Evaluation of differential effects of metformin treatment in obese children according to pubertal stage and genetic variations: study protocol for a randomized controlled trial.

Belén Pastor-Villaescusa, Javier Caballero-Villarraso, M Dolores Cañete, Raúl Hoyos, José Maldonado, Gloria Bueno, Rosaura Leis, Ángel Gil, Ramón Cañete, Concepción M Aguilera

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.2field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 9 citations in OpenAlex.

  1. Review
  2. Short-Term Metformin Treatment EnrichesFrontiers in microbiology · 2022
    Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 8 institutions in 1 country.

Belén Pastor-VillaescusaDepartment of Biochemistry and Molecular Biology II, Institute of Nutrition and Food Technology, Center of Biomedical Research Laboratory 123, University of Granada, Avenida del Conocimiento s/n. 18006 Armilla, Granada, Spain.
Javier Caballero-VillarrasoClinical Analysis Services. IMIBIC/Reina Sofía Hospital, Córdoba University, Córdoba, Spain.
M Dolores CañetePAIDI CTS-329. Maimonides Institute of Biomedical Research of Córdoba (IMIBIC), Córdoba, Spain.
Raúl HoyosPediatric Department, Virgen de las Nieves University Hospital, Andalusian Health Service, Granada, Spain.
José MaldonadoPediatric Gastroenterology and Nutrition Unit, Virgen de las Nieves University Hospital, Pediatric Department, University of Granada, Granada, Spain.
Gloria BuenoPediatric Department, Lozano Blesa University Clinical Hospital, University of Zaragoza, Zaragoza, Spain.
Rosaura LeisUnit of Investigation in Nutrition, Growth and Human Development of Galicia, Pediatric Department, Clinic University Hospital of Santiago, University of Santiago de Compostela, Santiago de Compostela, Spain.
Ángel GilDepartment of Biochemistry and Molecular Biology II, Institute of Nutrition and Food Technology, Center of Biomedical Research Laboratory 123, University of Granada, Avenida del Conocimiento s/n. 18006 Armilla, Granada, Spain.
Ramón CañeteUnit of Pediatric Endocrinology, Reina Sofia University Hospital, Córdoba, Spain.
Concepción M AguileraDepartment of Biochemistry and Molecular Biology II, Institute of Nutrition and Food Technology, Center of Biomedical Research Laboratory 123, University of Granada, Avenida del Conocimiento s/n. 18006 Armilla, Granada, Spain. caguiler@ugr.es.
Hospital Universitario Reina Sofía · ESUniversidad de Granada · ESAndalusian Health Service · ESCentro de Investigación Biomédica en Red · ESHospital Universitario Virgen de las Nieves · ESInstituto Maimónides de Investigación Biomédica de Córdoba · ESUniversidad de Zaragoza · ESUniversidade de Santiago de Compostela · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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. DISCUSSION: This 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.

Indexed as

Pharmacogenomic VariantsPolymorphism, GeneticPubertyAdolescentAge FactorsBiomarkersBody Mass IndexChildClinical ProtocolsDouble-Blind MethodFemaleGastrointestinal MicrobiomeGastrointestinal TractHealthy LifestyleHumansHypoglycemic AgentsBiomarkersHypoglycemic AgentsMetforminChildrenLifestyle interventionMetforminMicrobiotaObesityPolymorphismsPuberty

Identifiers

PMID27432166
PMCPMC4950074
OpenAlexW2495063022

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.