Effects of Exercise and/or β-hydroxy-β-methylbutyrate Supplementation on Muscle Mass, Physical Performance and Insulin Resistance in Older Diabetes With Low Muscle Mass: a Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- muscle mass
研究概览
简要总结
The investigators aimed to examine if β-hydroxy-β-methylbutyrate (HMB) supplementation enhances the effects of exercise on muscle mass, physical performance and insulin resistance and observe potential residual effects in older diabetes with low muscle mass, and to find the optimal treatment plan.
详细描述
The interaction between exercise and nutritional supplementation is unclear among older diabetes at risk of sarcopenia. The investigators aimed to examine if β-hydroxy-β-methylbutyrate (HMB) supplementation enhances the effects of exercise on muscle mass, physical performance and insulin resistance and observe potential residual effects in older diabetes with low muscle mass, and to find the optimal treatment plan. This 12-wk, randomized, double-blind, placebo controlled, 2 × 2 factorial design (exercise-only, HMB-only, both, and none) trial included 120 older diabetes aged 60-80 y with skeletal muscle index <5.7 kg/m2 for women, and <7.0 kg/m2 for men, and was followed by a 12-wk observational period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 60-80 ;
- •Diagnosis of T2DM
- •Low muscle mass: met a reference value for low muscle mass defined by the Asian Working Group for Sarcopenia (AWGS) criteria with skeletal muscle index <5.7 kg/m2 for women and <7.0 kg/m2 for men
排除标准
- •Individuals who had an organic disease of the nervous system;
- •Who were restricted from engaging in exercise by a medical doctor;
- •Who was unconscious and unable to complete the questionnaire;
- •Who used other supplementations for muscle mass gain;
- •Who had impaired cardiac, kidney, or liver function.
结局指标
主要结局
muscle mass
时间窗: 0 and 12 weeks
Body composition including muscle mass was measured using a segmental multifrequency bioelectrical impedance device (Inbody)
Handgrip strength
时间窗: 0 and 12 weeks
Handgrip strength was measured using a handheld Smedley-type dynamometer.
5-repetition sit-to-stand time
时间窗: 0 and 12 weeks
Participants folded their arms across their chests and were instructed to stand-up completely and make firm contact when sitting. Timing began on the command "go" and ceased when the participants sat after the fifth stand-up. Participants were allowed a practice trial of 2 repetitions before the timing of 2 test trials of 5 repetitions.
次要结局
- insulin resistance index(0 and 12 weeks)
研究者
Wu Shangling
Doctor
First Affiliated Hospital, Sun Yat-Sen University