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Study of Efficacy of Metformin in the Treatment of Acanthosis Nigricans in Children With Obesity

NCT02438020 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-05-08

No results posted yet for this study

Summary

Obesity is often accompanied by insulin resistance and/or hyperinsulinemia. Acanthosis nigricans (AN) is a skin condition commonly present on the neck of obese children. Metformin is a useful drug for conditions characterized by insulin resistance.The aim of this study is to compare the efficacy of metformin versus placebo on AN lesions of the neck as well as their effects on metabolic and anthropometric variables in a sample of obese children. This is a 12-week randomized, double-blind randomized trial involving obese children with AN to receive either metformin or placebo.

Evaluations will be performed every three weeks. Clinical, histological and colorimetric assessments of AN lesions will be compared initially and at the conclusion of the study.

Conditions

  • Acanthosis Nigricans

Interventions

DRUG

Metformin

One tablet of 500 mg will be ingested before the main meal

OTHER

Placebo

A placebo tablet will be ingested daily before main meal.

Sponsors & Collaborators

  • Hospital Central "Dr. Ignacio Morones Prieto"

    collaborator OTHER

  • Juan Pablo Castanedo-Cazares

    lead OTHER

Principal Investigators

  • Bertha Torres-Alvarez, MD · Hospital Central "Dr. Ignacio Morones Prieto"

  • Juan P Castanedo-Cazares, MD · Hospital Central "Dr. Ignacio Morones Prieto"

  • Francisco Goldaracena-Orozco, MD · Hospital Central "Dr. Ignacio Morones Prieto"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-06-30
Completion
2016-10-31

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs

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 NCT02438020 on ClinicalTrials.gov