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

Brief Title

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

Official Title

Double-blind Randomized Trial Using Oral Metformin Versus Placebo in the Treatment of Acanthosis Nigricans in Children With Obesity

Brief 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.
    

Detailed Description

      Acanthosis nigricans (AN) are lesions affecting localized areas of the skin in persons with
      obesity and/or hyperinsulinemia. Roughening of the skin is related with histological
      papillomatosis and the skin darkening is due to hyperkeratosis. Biochemical mechanisms for
      developing this hyperplastic lesion involve local cutaneous growth factors. Nearly 40% of
      Native American teenagers have acanthosis nigricans, whereas about 13% of African American,
      6% of Hispanic, and less than 1% of white, non-Hispanic children aged 10-19 have clinically
      apparent acanthosis nigricans. AN is a clinical surrogate of laboratory-documented
      hyperinsulinemia.

      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 (HOMA, triglycerides, cholesterol) and
      anthropometric variables (BMI, waist) 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.
      Burke´s scale, papillomatosis and hyperkeratosis, and the L* axis of will be used to measure
      the AN improvement.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Clinical improvement of acanthosis nigricans

Secondary Outcome

 Histological improvement of acanthosis nigricans

Condition

Acanthosis Nigricans

Intervention

Metformin

Study Arms / Comparison Groups

 Metformin
Description:  500 mg metformin oral intake before main meal

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

30

Start Date

June 2015

Completion Date

October 2016

Primary Completion Date

June 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Signed informed consent from children and parents.

          -  Children younger than 18 years.

          -  Clinical diagnosis of acanthosis nigricans.

          -  Obesity.

        Exclusion Criteria:

          -  Diabetes mellitus.

          -  Neurological diseases.

          -  Congenital diseases.

          -  Oral treatment for obesity in the last two months.

          -  Topical treatment for the last two months.
      

Gender

All

Ages

8 Years - 17 Years

Accepts Healthy Volunteers

No

Contacts

Bertha Torres-Alvarez, MD, 524448342795, [email protected]

Location Countries

Mexico

Location Countries

Mexico

Administrative Informations


NCT ID

NCT02438020

Organization ID

MET-AN


Responsible Party

Sponsor-Investigator

Study Sponsor

Juan Pablo Castanedo-Cazares

Collaborators

 Hospital Central "Dr. Ignacio Morones Prieto"

Study Sponsor

Bertha Torres-Alvarez, MD, Study Chair, Hospital Central "Dr. Ignacio Morones Prieto"


Verification Date

May 2015