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

NCT02438020 | Unknown Phase 4

• 1 other identifier: MET-AN
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Acanthosis Nigricans

Keywords

Acanthosis nigricans; obesity; children; metformin

Outcome Measures

Primary Outcomes (1)

• Clinical improvement of acanthosis nigricans

  Initial and after intervention assessment of acanthosis nigricans using the quantitative scale of Burke (Diabetes Care 22:1655-1659, 1999). Five anatomical sites were chosen to assess the presence and extent of AN: neck, axilla, knuckles, elbows, and knees. The neck and axilla are graded for severity on a scale from 0 to 4. For AN present on the neck, texture of the affected area is also measured on a scale from 0 to 3. Knuckles, elbows, and knees are graded as AN present (1) or absent (0). Score goes from 0 to 14.

  baseline and 12 weeks

Secondary Outcomes (2)

• Histological improvement of acanthosis nigricans

  baseline and 12 weeks

• Depigmentation of acanthosis nigricans

  baseline and 12 weeks

Other Outcomes (5)

• Serum fasting insulin

  baseline and 12 weeks

• Serum fasting glucose

  baseline and 12 weeks

• Serum fasting lipids

  baseline and 12 weeks

Study Arms (2)

Metformin

EXPERIMENTAL

500 mg metformin oral intake before main meal

Drug: Metformin

Placebo

PLACEBO COMPARATOR

Placebo tablet before main meal.

Other: Placebo

Interventions

Metformin DRUG

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

Also known as: Glucophage, Glumetza, Fortamet, Riomet

Metformin

Placebo OTHER

A placebo tablet will be ingested daily before main meal.

Placebo

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Signed informed consent from children and parents.
• Children younger than 18 years.
• Clinical diagnosis of acanthosis nigricans.
• Obesity.

You may not qualify if:

• Diabetes mellitus.
• Neurological diseases.
• Congenital diseases.
• Oral treatment for obesity in the last two months.
• Topical treatment for the last two months.

Sponsors & Collaborators

• Juan Pablo Castanedo-Cazares: lead
• Hospital Central "Dr. Ignacio Morones Prieto": collaborator

Study Sites (1)

Hospital Central Dr.Ignacio Morones Prieto

San Luis Potosí City, San Luis Potosí, 78210, Mexico

Location

Related Publications (3)

• 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.

  PMID: 17039655 BACKGROUND

• 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.

  PMID: 11335776 BACKGROUND

• 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.

  PMID: 18492785 BACKGROUND

MeSH Terms

Conditions

Acanthosis Nigricans; Obesity

Interventions

Metformin

Condition Hierarchy (Ancestors)

Melanosis; Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Bertha Torres-Alvarez, MD

  Hospital Central "Dr. Ignacio Morones Prieto"

  STUDY CHAIR

• Juan P Castanedo-Cazares, MD

  Hospital Central "Dr. Ignacio Morones Prieto"

  STUDY DIRECTOR

• Francisco Goldaracena-Orozco, MD

  Hospital Central "Dr. Ignacio Morones Prieto"

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan P Castanedo-Cazares, MD

CONTACT

524448342795; castanju@yahoo.com

Francisco Goldaracena-Orozco, MD

CONTACT

524448342795; goldarac@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dermatology research director

Study Record Dates

• First Submitted: May 3, 2015
• First Posted: May 8, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: October 1, 2016
• Last Updated: May 8, 2015

Record last verified: 2015-05

Locations

ME (1)