Adipokines in Obese Adolescents With Insulin Resistance

NCT01410604 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2012-04-27

Study results available
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Summary

The purpose of this study is to compare serum concentrations of inflammatory cytokines, interleukin 6 (IL-6), High-sensitivity C-reactive protein (hs-CRP), adiponectin, and tumour necrosis factor alpha (TNFα), before and after three months treatment with metformin in obese adolescents with insulin resistance (IR).

Conditions

Interventions

DRUG

Metformin

Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months.

DRUG

Placebo

Tablet of 500 mg oral placebo every 12 hours for 3 months.

Sponsors & Collaborators

  • Hospital Infantil de Mexico Federico Gomez

    collaborator OTHER
  • Hospital Regional de Alta Especialidad del Bajio

    lead OTHER

Principal Investigators

  • Maria L Evia-Viscarra, M.D. · Hospital Regional de Alta Especialidad del Bajio

  • Edel R Rodea-Montero, Statistician · Hospital Regional de Alta Especialidad del Bajio

  • Evelia Apolinar-Jiménez, Nutrition · Hospital Regional de Alta Especialidad del Bajio

  • Leticia M García-Morales, M.D. · Hospital Infantil de Mexico Federico Gomez

  • Constanza Leaños-Pérez, M.D. · Hospital Infantil de Mexico Federico Gomez

  • Mireya Figueroa-Barrón, Chemestry · Hospital Infantil de Mexico Federico Gomez

  • Dolores Sánchez-Fierros, Chemestry · Hospital Infantil de Mexico Federico Gomez

  • Nathalie Muñoz-Noriega, Nutrition · Hospital Regional de Alta Especialidad del Bajio

  • Juan G Reyes-García, M.D. · Escuela Superior de Medicina del IPN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2009-12-31
Completion
2010-03-31

Countries

  • Mexico

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01410604 on ClinicalTrials.gov