Clinical trial NCT02438020: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acanthosis Nigricans
Keywords: Acanthosis nigricans
obesity
children
metformin
Lead sponsor: Universidad Autonoma de San Luis Potosí
Sponsor class: OTHER
Collaborators: name: Hospital Central "Dr. Ignacio Morones Prieto"
First posted: 2015-05-08
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Clinical improvement of acanthosis nigricans
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: Histological improvement of acanthosis nigricans
timeFrame: baseline and 12 weeks
measure: Depigmentation of acanthosis nigricans
timeFrame: baseline and 12 weeks
Other outcomes:
measure: Serum fasting insulin
timeFrame: baseline and 12 weeks
measure: Serum fasting glucose
timeFrame: baseline and 12 weeks
measure: Serum fasting lipids
timeFrame: baseline and 12 weeks
measure: Waist measurement
timeFrame: baseline and 12 weeks
measure: Quantification of Body mass index (BMI)
timeFrame: baseline and 12 weeks
Locations:
city: San Luis Potosi
country: Mexico
facility: Hospital Central Dr.Ignacio Morones Prieto
state: SLP
Study officials:
affiliation: Hospital Central "Dr. Ignacio Morones Prieto"
name: Bertha Torres-Alvarez, MD
role: STUDY_CHAIR
affiliation: Hospital Central "Dr. Ignacio Morones Prieto"
name: Juan P Castanedo-Cazares, MD
role: STUDY_DIRECTOR
affiliation: Hospital Central "Dr. Ignacio Morones Prieto"
name: Francisco Goldaracena-Orozco, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bellot-Rojas P, Posadas-Sanchez R, Caracas-Portilla N, Zamora-Gonzalez J, Cardoso-Saldana G, Jurado-Santacruz F, Posadas-Romero C. Comparison of metformin versus rosiglitazone in patients with Acanthosis nigricans: a pilot study. J Drugs Dermatol. 2006 Oct;5(9):884-9.
citation: Freemark M, Bursey D. The effects of metformin on body mass index and glucose tolerance in obese adolescents with fasting hyperinsulinemia and a family history of type 2 diabetes. Pediatrics. 2001 Apr;107(4):E55. doi: 10.1542/peds.107.4.e55.
citation: Romo A, Benavides S. Treatment options in insulin resistance obesity-related acanthosis nigricans. Ann Pharmacother. 2008 Jul;42(7):1090-4. doi: 10.1345/aph.1K446. Epub 2008 May 20.