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| Name | Class |
|---|---|
| Hospital Central "Dr. Ignacio Morones Prieto" | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Experimental | 500 mg metformin oral intake before main meal |
|
| Placebo | Placebo Comparator | Placebo tablet before main meal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | One tablet of 500 mg will be ingested before the main meal |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Depigmentation of acanthosis nigricans |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Serum fasting glucose | Quantification of serum fasting glucose in mg/dL. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan P Castanedo-Cazares, MD | Contact | 524448342795 | castanju@yahoo.com | |
| Francisco Goldaracena-Orozco, MD | Contact | 524448342795 | goldarac@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Central Dr.Ignacio Morones Prieto | San Luis Potosà City | San Luis Potosà | 78210 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17039655 | Background | 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. | |
| 11335776 | 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. |
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| ID | Term |
|---|---|
| D000052 | Acanthosis Nigricans |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D008548 | Melanosis |
| D017495 | Hyperpigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Placebo | Other | A placebo tablet will be ingested daily before main meal. |
|
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 |
| baseline and 12 weeks |
| Serum fasting lipids | Quantification of serum fasting lipids in mg/dL. Cholesterol (HDL, LDL, VLDL) and triglycerides. | baseline and 12 weeks |
| Waist measurement | Waist measurement in centimeters. | baseline and 12 weeks |
| 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 |
| Francisco Goldaracena-Orozco, MD |
| Hospital Central "Dr. Ignacio Morones Prieto" |
| Principal Investigator |
| 18492785 | 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. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |