Double-blind Randomized Trial Using Oral Metformin Versus Placebo in the Treatment of Acanthosis Nigricans in Children With Obesity
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinical improvement of acanthosis nigricans
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent from children and parents.
- •Children younger than 18 years.
- •Clinical diagnosis of acanthosis nigricans.
排除标准
- •Diabetes mellitus.
- •Neurological diseases.
- •Congenital diseases.
- •Oral treatment for obesity in the last two months.
- •Topical treatment for the last two months.
研究组 & 干预措施
Metformin
500 mg metformin oral intake before main meal
干预措施: Metformin (Drug)
Placebo
Placebo tablet before main meal.
干预措施: Placebo (Other)
结局指标
主要结局
Clinical improvement of acanthosis nigricans
时间窗: 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.
次要结局
- Depigmentation of acanthosis nigricans(baseline and 12 weeks)
- Histological improvement of acanthosis nigricans(baseline and 12 weeks)
研究者
Juan Pablo Castanedo-Cazares
Dermatology research director
Universidad Autonoma de San Luis Potosí