Study of Efficacy of Metformin in the Treatment of Acanthosis Nigricans in Children With Obesity
NCT ID: NCT02438020
Last Updated: 2015-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
30 participants
INTERVENTIONAL
2015-06-30
2016-10-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Metformin
500 mg metformin oral intake before main meal
Metformin
One tablet of 500 mg will be ingested before the main meal
Placebo
Placebo tablet before main meal.
Placebo
A placebo tablet will be ingested daily before main meal.
Interventions
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Metformin
One tablet of 500 mg will be ingested before the main meal
Placebo
A placebo tablet will be ingested daily before main meal.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Children younger than 18 years.
* Clinical diagnosis of acanthosis nigricans.
* Obesity.
Exclusion Criteria
* Neurological diseases.
* Congenital diseases.
* Oral treatment for obesity in the last two months.
* Topical treatment for the last two months.
8 Years
17 Years
ALL
No
Sponsors
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Hospital Central "Dr. Ignacio Morones Prieto"
OTHER
Juan Pablo Castanedo-Cazares
OTHER
Responsible Party
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Juan Pablo Castanedo-Cazares
Dermatology research director
Principal Investigators
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Bertha Torres-Alvarez, MD
Role: STUDY_CHAIR
Hospital Central "Dr. Ignacio Morones Prieto"
Juan P Castanedo-Cazares, MD
Role: STUDY_DIRECTOR
Hospital Central "Dr. Ignacio Morones Prieto"
Francisco Goldaracena-Orozco, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Central "Dr. Ignacio Morones Prieto"
Locations
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Hospital Central Dr.Ignacio Morones Prieto
San Luis Potosí City, San Luis Potosí, Mexico
Countries
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Central Contacts
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References
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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.
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.
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.
Other Identifiers
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MET-AN
Identifier Type: -
Identifier Source: org_study_id
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