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

Acanthosis Nigricans Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02438020
• Other study ID #: MET-AN
• Status: Not yet recruiting
• Phase: Phase 4
• First received: May 3, 2015
• Last updated: May 5, 2015
• Start date: June 2015
• Est. completion date: October 2016

Study information

• Verified date: May 2015
• Source: Universidad Autonoma de San Luis Potosí
• Contact: Juan P Castanedo-Cazares, MD
• Phone: 524448342795
• Email: castanju[@]yahoo.com
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 17 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acanthosis Nigricans

Intervention

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.

Locations

Country	Name	City	State
Mexico	Hospital Central Dr.Ignacio Morones Prieto	San Luis Potosi	SLP

Sponsors (2)

Lead Sponsor	Collaborator
Juan Pablo Castanedo-Cazares	Hospital Central "Dr. Ignacio Morones Prieto"

Country where clinical trial is conducted

Mexico, 

References & Publications (3)

Bellot-Rojas P, Posadas-Sanchez R, Caracas-Portilla N, Zamora-Gonzalez J, Cardoso-Saldaña 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum fasting insulin	Quantification of serum fasting insulin in pmol/L or mIU/L, at baseline and at the end of the study.	baseline and 12 weeks	No
Other	Serum fasting glucose	Quantification of serum fasting glucose in mg/dL.	baseline and 12 weeks	No
Other	Serum fasting lipids	Quantification of serum fasting lipids in mg/dL. Cholesterol (HDL, LDL, VLDL) and triglycerides.	baseline and 12 weeks	No
Other	Waist measurement	Waist measurement in centimeters.	baseline and 12 weeks	No
Other	Quantification of Body mass index (BMI)	BMI It is the measure of body fat based on height and weight. The BMI is the body mass divided by the square of the body height, and expressed in units of kg/m2, resulting from weight in kilograms and height in metres	baseline and 12 weeks	No
Primary	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	No
Secondary	Histological improvement of acanthosis nigricans	Epidermal and stratum corneum thickness of 3 mm skin samples obtained from neck will be measured using an image processing software initially and at the end of trial.	baseline and 12 weeks	No
Secondary	Depigmentation of acanthosis nigricans	Quantification of pigmentation change of lesions by means of the L axis of the CIE system. 0 is pure white, 100 y total dark. Initially, and at the end of study.	baseline and 12 weeks	No