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