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

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ClinicalTrials.gov Identifier: NCT02438020
Recruitment Status : Unknown
Verified May 2015 by Juan Pablo Castanedo-Cazares, Universidad Autonoma de San Luis Potosí.
Recruitment status was:  Not yet recruiting
First Posted : May 8, 2015
Last Update Posted : May 8, 2015
Sponsor:
Collaborator:
Hospital Central "Dr. Ignacio Morones Prieto"
Information provided by (Responsible Party):
Juan Pablo Castanedo-Cazares, Universidad Autonoma de San Luis Potosí

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.


Condition or disease Intervention/treatment Phase
Acanthosis Nigricans Drug: Metformin Other: Placebo Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Double-blind Randomized Trial Using Oral Metformin Versus Placebo in the Treatment of Acanthosis Nigricans in Children With Obesity
Study Start Date : June 2015
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Metformin
500 mg metformin oral intake before main meal
Drug: Metformin
One tablet of 500 mg will be ingested before the main meal
Other Names:
  • Glucophage
  • Glumetza
  • Fortamet
  • Riomet

Placebo Comparator: Placebo
Placebo tablet before main meal.
Other: Placebo
A placebo tablet will be ingested daily before main meal.




Primary Outcome Measures :
  1. Clinical improvement of acanthosis nigricans [ Time Frame: baseline and 12 weeks ]

    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.



Secondary Outcome Measures :
  1. Histological improvement of acanthosis nigricans [ Time Frame: baseline and 12 weeks ]
    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.

  2. Depigmentation of acanthosis nigricans [ Time Frame: baseline and 12 weeks ]
    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.


Other Outcome Measures:
  1. Serum fasting insulin [ Time Frame: baseline and 12 weeks ]
    Quantification of serum fasting insulin in pmol/L or mIU/L, at baseline and at the end of the study.

  2. Serum fasting glucose [ Time Frame: baseline and 12 weeks ]
    Quantification of serum fasting glucose in mg/dL.

  3. Serum fasting lipids [ Time Frame: baseline and 12 weeks ]
    Quantification of serum fasting lipids in mg/dL. Cholesterol (HDL, LDL, VLDL) and triglycerides.

  4. Waist measurement [ Time Frame: baseline and 12 weeks ]
    Waist measurement in centimeters.

  5. Quantification of Body mass index (BMI) [ Time Frame: baseline and 12 weeks ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02438020


Contacts
Contact: Juan P Castanedo-Cazares, MD 524448342795 castanju@yahoo.com
Contact: Francisco Goldaracena-Orozco, MD 524448342795 goldarac@hotmail.com

Locations
Mexico
Hospital Central Dr.Ignacio Morones Prieto Active, not recruiting
San Luis Potosi, SLP, Mexico, 78210
Sponsors and Collaborators
Juan Pablo Castanedo-Cazares
Hospital Central "Dr. Ignacio Morones Prieto"
Investigators
Study Chair: Bertha Torres-Alvarez, MD Hospital Central "Dr. Ignacio Morones Prieto"
Study Director: Juan P Castanedo-Cazares, MD Hospital Central "Dr. Ignacio Morones Prieto"
Principal Investigator: Francisco Goldaracena-Orozco, MD Hospital Central "Dr. Ignacio Morones Prieto"

Publications:
Responsible Party: Juan Pablo Castanedo-Cazares, Dermatology research director, Universidad Autonoma de San Luis Potosí
ClinicalTrials.gov Identifier: NCT02438020     History of Changes
Other Study ID Numbers: MET-AN
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: May 8, 2015
Last Verified: May 2015

Keywords provided by Juan Pablo Castanedo-Cazares, Universidad Autonoma de San Luis Potosí:
Acanthosis nigricans
obesity
children
metformin

Additional relevant MeSH terms:
Acanthosis Nigricans
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs