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临床试验/NCT02957916
NCT02957916已完成不适用

Vanderbilt Childhood Obesity Registry

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2012年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,000
试验地点
1
主要终点
Prevalence of genetic mutations in DNA analysis

研究概览

简要总结

In order to better understand early onset obesity and to identify patients in interested in future research studies, including clinical trials, we aim to develop a registry for patients with early onset obesity.

详细描述

Obesity is an epidemic effecting the pediatric population. Currently, 17% of children are classified as obese and 32% as overweight. Many of these children develop complications including type 2 diabetes, dyslipidemia, hypertension and hepatic steatosis. Obesity is a global epidemic that lacks effective treatment options. Obesity has many underlying causes including genetic predisposition and environmental factors. Understanding the genetic basis of obesity may allow for more precisely targeted interventions including specific dietary plans and pharmacologic treatments. The most common cause of genetic obesity is haploinsufficiency of the melanocortin-4 receptor (MC4R). In obese adult cohorts, the prevalence of pathogenic MC4R mutations is 1-2%. Commercial testing is available for many obesity syndromes, but the cost is high and charges are not always covered by insurance. Clinicians have little motivation to test patients for MC4R mutations as no treatments are available and it is not clear if genetic testing results change patient behavior. This particular lab and other groups are working to develop novel pharmacologic treatments for obesity syndromes, such as MC4R deficiency. In order to better understand early onset obesity and to identify patients in interested in future research studies, including clinical trials, the investigators aim to develop a registry for patients with early onset obesity.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
2 Years 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI >97th percentile for age and gender before 6 years old
  • Able to give written, informed consent/assent

排除标准

  • Diagnosis of Prader-Willi syndrome
  • Use of exogenous steroids or other medications known to cause abnormal weight gain
  • Cushing's syndrome, untreated growth hormone deficiency or untreated hypothyroidism as an etiology for the obesity
  • Hypothalamic obesity (obesity due to a brain tumor, head trauma or other brain lesion)
  • Currently pregnant

结局指标

主要结局

Prevalence of genetic mutations in DNA analysis

时间窗: 5 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ashley Shoemaker

MD, MSCI

Vanderbilt University Medical Center

研究点 (1)

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