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临床试验/NCT03430115
NCT03430115已完成不适用

Long-term Function and Health Effects of Intentional Weight Loss in Obese Elders

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 588 人开始时间: 2018年2月20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
588
试验地点
1
主要终点
400 meter walk time

研究概览

简要总结

Aging is associated with significant declines in muscle mass, strength, and physical performance, all of which lead to disability, loss of independence, and adverse clinical outcomes. Obesity exacerbates these age-related declines in function and is associated with poorer clinical outcomes and quality of life. Weight loss can also worsen age-related loss of muscle mass and decrease bone mineral density. The overall goals of this study are to determine if the short-term functional benefits of intentional weight loss are sustained long-term, and to examine the long-term benefits and risks of weight loss.

详细描述

Obesity exacerbates age-related declines in function and is associated with poorer clinical outcomes and quality of life. Although clinical trials conducted study teams show that diet-induced weight loss interventions in obese older adults, when combined with exercise, improve body composition and physical and metabolic function in the short-term, the overall safety and long-term benefits of intentional weight loss in older adults remain controversial. Weight loss can also worsen age-related loss of muscle mass and decrease bone mineral density. Because of these concerns, health care providers are reluctant to recommend weight loss in obese older adults. The goal is to determine whether weight loss-induced improvements in body composition and physical and metabolic function observed in short-term clinical trials persist over time is critical to inform geriatric obesity treatment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All former participants from the five intervention trials who respond to our recruitment strategies will be scheduled for clinic/home visits or a phone interview.

排除标准

  • None - all former participants from the five intervention trials are eligible

结局指标

主要结局

400 meter walk time

时间窗: Baseline

Participants are instructed to complete the 400 m distance (on a flat indoor surface) as quickly as possible at a maintainable pace and the time to complete the walk is recorded in seconds.

次要结局

  • Knee extension strength(Baseline)
  • Total body fat mass(Baseline)
  • Subcutaneous abdominal fat(Baseline)
  • Appendicular lean mass(Baseline)
  • Interleukin-6(Baseline)
  • Glucose(Baseline)
  • Insulin(Baseline)
  • LDL cholesterol(Baseline)
  • Short Physical Performance Battery score(Baseline)
  • Total body lean mass(Baseline)
  • Femoral neck BMD(Baseline)
  • Lumbar spine BMD(Baseline)
  • Visceral abdominal fat(Baseline)
  • Diastolic blood pressure(Baseline)
  • Soluble tumor necrosis factor receptor 1(Baseline)
  • Total hip BMD(Baseline)
  • Thigh inter-muscular adipose tissue(Baseline)
  • Total cholesterol(Baseline)
  • Systolic blood pressure(Baseline)
  • HDL cholesterol(Baseline)
  • Triglycerides(Baseline)
  • C-reactive protein(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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