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临床试验/NCT03947697
NCT03947697招募中不适用

Improving Glycemic Control with Electrical Stimulation in Mexican-Americans

University of Texas, El Paso1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年8月9日最近更新:
适应症
干预措施

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

Placebo Comparator

Participants will receive stimulation only up to sensory level.

干预措施: Neuromuscular Electrical Stimulation (Sensory) (Device)

NMES

Experimental

Participants will receive stimulation up to maximum tolerable level.

干预措施: Neuromuscular Electrical Stimulation (Device)

Resistance Training

Placebo Comparator

Participants will receive exercise training with stimulation up to sensory level.

干预措施: Neuromuscular Electrical Stimulation (Sensory) (Device)

Resistance Training

Placebo Comparator

Participants will receive exercise training with stimulation up to sensory level.

干预措施: Resistance Training (Other)

Resistance Training + NMES

Experimental

Participants will receive exercise training with stimulation up to maximum tolerable intensity.

干预措施: Neuromuscular Electrical Stimulation (Device)

Resistance Training + NMES

Experimental

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

发起方
University of Texas, El Paso
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sudip Bajpeyi

Associate Professor

University of Texas, El Paso

研究点 (1)

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