Improving Glycemic Control with Electrical Stimulation in Mexican-Americans
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Glycemic Control
研究概览
简要总结
Once written consent is obtained, the participant will be provided with an accelerometer to be worn for 7 days to assess current physical activity levels. Subjects will be provided with a standardized diet (55/15/30% CHO/PRO/FAT) prior to collection of pre-intervention data of insulin sensitivity. Individuals will then participate in an 8-week electrical stimulation intervention (30min/day, 3x/week) and randomized into placebo/control, NMES, resistance training combined with NMES (RT +NMES), or resistance training (RT) group (n=15 per group), followed by collection of post-intervention data. The control group will receive electrical stimulation up to sensory level, the NMES group will receive stimulation up to tolerable intensity to induce visible muscle contraction, the RT+ NMES will receive stimulation up to tolerable intensity during resistance training, and the RT group will only receive exercise training. Pre-and post-intervention data includes measurements for body composition, resting metabolic rate, VO2max, insulin sensitivity, and comprehensive blood work.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overweight/Obese (BMI ≥25)
- •Sedentary Lifestyle: Physical Activity Level<1.4
- •Less than 150min/week of structured Exercise
排除标准
- •Use of anti-hypertensive, lipid-lowering or insulin sensitizing medications
- •Excessive alcohol, drug abuse, smoking
- •Pregnant Women
- •Unwilling to adhere to the study Intervention
研究组 & 干预措施
Control
Participants will receive stimulation only up to sensory level.
干预措施: Neuromuscular Electrical Stimulation (Sensory) (Device)
NMES
Participants will receive stimulation up to maximum tolerable level.
干预措施: Neuromuscular Electrical Stimulation (Device)
Resistance Training
Participants will receive exercise training with stimulation up to sensory level.
干预措施: Neuromuscular Electrical Stimulation (Sensory) (Device)
Resistance Training
Participants will receive exercise training with stimulation up to sensory level.
干预措施: Resistance Training (Other)
Resistance Training + NMES
Participants will receive exercise training with stimulation up to maximum tolerable intensity.
干预措施: Neuromuscular Electrical Stimulation (Device)
Resistance Training + NMES
Participants will receive exercise training with stimulation up to maximum tolerable intensity.
干预措施: Resistance Training (Other)
结局指标
主要结局
Glycemic Control
时间窗: 8 weeks
Insulin Sensitivity will be measured through repeated blood sampling during an Oral Glucose Tolerance Test and Continuous Glucose Monitoring
次要结局
- Respiratory Exchange Ratio(8 Weeks)
- Amount of lean mass(8 Weeks)
研究者
Sudip Bajpeyi
Associate Professor
University of Texas, El Paso
