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临床试验/NCT02040727
NCT02040727已完成不适用

Communications of Muscle and Bone

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
Fasting plasma FGF-23 concentration

研究概览

简要总结

This project will evaluate the impact of resistance training on the synthesis and release of hormones and growth factors from the musculoskeletal system and the extent to which the communicative capacity influences glucose homeostasis In turn, the contribution of glucose regulation on the musculoskeletal system will also be evaluated. This small study will serve as a pilot/feasibility study to define a protocol for implementation of a resistance training intervention in the pediatric population. To establish feasibility, this study population is limited to overweight African American boys ages 7-11 years.

In light of well-established accolades of resistance training, historical recommendations for avoidance among the pediatric population have deterred implementation of resistance training interventions in young adolescents. However, contemporary data indicating a profound benefit of resistance training to the skeletal system in pre-adolescents has led to the Academy of Sports Medicine, as well as various other pediatric health interest groups, to support supervised programs incorporating resistance training in young children, emphasizing large muscle and core strengthening. To date, such trials have not been conducted in the pediatric population

详细描述

Early adolescence (pre-puberty) is associated with many physiological changes with the intersection of metabolic pathways and body composition at the core. Lifestyle behaviors provide substantial influence and the rise of sedentary behavior particularly among this population can exert profound disruption. Metabolic dysfunction associated with limited activity and thus limited strain on the muscles and bones is associated with poor musculoskeletal health. Metabolic disturbance within the system during critical periods of development such as pre-puberty confers long-term health consequences.

Communication across systems is reliant upon various hormones which interact on the regulation of glucose homeostasis, bone metabolism, and muscle development. While it is well-established that bone and muscle growth are dependent upon fuel utilization, factors secreted by bone and muscle have been recently shown to play an interactive role in glucose homeostasis. Data derived primarily from animal models have demonstrated maintenance of physiological levels promote optimal growth and development, whereas these hormones appear to have adverse effects when levels are altered. While the data in animals is compelling, translation in humans has not been conducted.

Speculatively, impaired glucose homeostasis, much attributable to decreased strain on the musculoskeletal system, promotes impairments in physiological roles of these hormones. As a result, disordered development may be of consequence, such that the bones grow bigger yet have impaired quality, and delivery of fuel to muscle is compromised. Obesity-induced perturbations in metabolism and tissue partitioning may be an added stress to the system, impairing muscle function, power, performance and overall quality. Strategies that optimize the protective effects of the musculoskeletal system may be encompassed by forced stress on the system via resistance training, known to influence synthesis and release of hormones involved in fuel delivery and utilization by muscle and bone. The strategy proposed will target optimization of musculoskeletal health, promoting synthesis and release of musculoskeletal-derived signals providing protection on metabolic health at a critical period of development.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
盲法
None

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • overweight
  • early pubertal boys (Tanner stage <3)
  • ages 7-12 years
  • self-identified as Non-Hispanic Black.

排除标准

  • type 1 or 2 diabetes
  • musculoskeletal disorders
  • disturbances in glucose or lipid metabolism
  • use of thyroid medication, diuretics, beta-blockers, or any medication that potentially could affect body composition, the lipid profile, insulin sensitivity, or blood pressure
  • allergy to EMLA cream
  • history of eating disorders, cancer, kidney disease, endocrinopathy, liver disease, heart disease, or thyroid disease
  • medically determined not to be able to engage in resistance training

结局指标

主要结局

Fasting plasma FGF-23 concentration

时间窗: 0,8,12,16, 24 weeks

Fibroblast Growth Factor-23

Fasting serum osteocalcin concentration

时间窗: 0, 8, 12, 16, 24 weeks

Fasting serum insulin concentration

时间窗: 0, 8, 12, 16, 24 weeks

Fasting serum glucose concentration

时间窗: 0, 8, 12, 16, 24 weeks

次要结局

  • Muscle density(0, 12, 24 weeks)
  • Bone stress-strain index(0, 12, 24 weeks)
  • Bone mineral content(0, 12, 24 weeks)
  • Muscle strength(0, 8, 12, 16, 24 weeks)

研究者

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

Lynae J. Hanks, PhD. RD

Post-Doctoral Fellow

University of Alabama at Birmingham

研究点 (2)

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