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临床试验/NCT01737658
NCT01737658已完成不适用

Insulin Resistance and Cognitive Dysfunction in Obese Adolescents: Pilot Study

NYU Langone Health2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2012年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
2
主要终点
Formal exercise intervention and cognitive dysfunction in obeses adolescents

研究概览

简要总结

Obese Adolescents will be evaluated for insulin resistance and cognitive dysfunction.

详细描述

The short-term goal of this project is to conduct a feasibility study at Winthrop University Hospital to determine how well extremely obese (BMI > 99%tile corrected for age) children and adolescents can be recruited into an exercise program and evaluated in an efficient fashion, and to identify particular strategies (e.g., medical examination feedback) that can serve as potential benefits to research subjects and their families. In addition investigators will evaluate the effect of the exercise program on physical fitness, insulin resistance, and neurocognitive functioning as well as the relationship between insulin sensitivity and neurocognitive function among adolescents who participate in the exercise program.

The long-term goal of this project is to evaluate a large, multi-ethnic sample of adolescents, 14 to 19 years of age, to systematically assess cognitive function and school performance, fitness and examine the relationship between performance on those outcome variables and a variety of biomedical and psychosocial factors that may directly or indirectly influence brain function and test-taking performance.

High body mass index (BMI) among children and adolescents continues to be a public health concern in the United States. The most recent figures from the National Health and Nutrition Examination Survey (NHANES) for 2007-2008 report that 18.1% (95% CI, 14.5%-21.7%) of 12- through 19-year-old adolescents were at or above the 95th percentile of BMI for age. Children with high BMI often become obese adults, and obese adults are at risk for many chronic conditions. High BMI in children may also have immediate consequences, such as elevated lipid concentrations and blood pressure.

It now appears that neurocognitive dysfunction is also more common in obese children and adolescents. In a large population study of 2,519 children, 8 to 16 years of age, a brief neuropsychological assessment showed a statistically significant, albeit modest relationship between cognitive test scores and BMI that persisted after adjusting for confounding variables. Obesity is also associated with several conditions which known to affect brain function, including sleep apnea, insulin resistance, hypertension, and chronic inflammatory factors (e.g., by these variables cannot be determined, unfortunately, because those variables were not measured.

It is important to note, however, that there is not complete agreement on linkages between obesity and cognition.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
14 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female subject's ages 14 to 19 years old, extremely obese (BMI ≥ 99th percentile).
  • Clearance by pediatric cardiologist, including evaluation of V02Max.

排除标准

  • Male and female less than 14years of age or more than 19 years of age.
  • Patients with type 1 or type 2 diabetes
  • Patients with serious medical conditions.
  • Anyone who is deemed inappropriate by pediatric cardiologist during clearance evaluation.

研究组 & 干预措施

Exercise Program upon enrollment

Other

Subject will receive exercise intervention immediately upon enrollment to study

干预措施: Exercise Program (Other)

Exercise Program 6 months after enrollment

Other

Subject will be enrolled into study and then receive exercise intervention 6 months after enrollment.

干预措施: Exercise Program (Other)

结局指标

主要结局

Formal exercise intervention and cognitive dysfunction in obeses adolescents

时间窗: 1 year

To measure the feasibility of recruiting extremely obese (BMI \> 99%tile corrected for age) children and adolescents into an exercise program and evaluate their physical fitness.

次要结局

  • Systemic and Cognitive effects of adding exercise program to obese adolescent's lifestyle.(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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