Improving Glycemic Control With Electrical Stimulation in Mexican-Americans

Study Overview
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Brief Summary
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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.

Official Title
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Improving Glycemic Control With Electrical Stimulation in Mexican-Americans

Conditions
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Obesity, Overweight, Insulin Resistance

Intervention / Treatment
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* Device: Neuromuscular Electrical Stimulation (Sensory)
* Device: Neuromuscular Electrical Stimulation
* Other: Resistance Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overweight/Obese (BMI ≥25) Sedentary Lifestyle: Physical Activity Level<1.4 Less than 150min/week of structured Exercise Exclusion Criteria: Use of anti-hypertensive, lipid-lowering or insulin sensitizing medications Excessive alcohol, drug abuse, smoking Pregnant Women Unwilling to adhere to the study Intervention

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Participants will receive stimulation only up to sensory level. | Device: Neuromuscular Electrical Stimulation (Sensory)<br>* Group will receive Electrical Stimulation up to sensory level<br>* Other names: Control;|
| Experimental: NMES<br>Participants will receive stimulation up to maximum tolerable level. | Device: Neuromuscular Electrical Stimulation<br>* Group will receive Electrical Stimulation up to maximum tolerable level<br>* Other names: NMES Group;|
| Placebo Comparator: Resistance Training<br>Participants will receive exercise training with stimulation up to sensory level. | Device: Neuromuscular Electrical Stimulation (Sensory)<br>* Group will receive Electrical Stimulation up to sensory level<br>* Other names: Control;Other: Resistance Training<br>* Group will receive exercise training.<br>|
| Experimental: Resistance Training + NMES<br>Participants will receive exercise training with stimulation up to maximum tolerable intensity. | Device: Neuromuscular Electrical Stimulation<br>* Group will receive Electrical Stimulation up to maximum tolerable level<br>* Other names: NMES Group;Other: Resistance Training<br>* Group will receive exercise training.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic Control | Insulin Sensitivity will be measured through repeated blood sampling during an Oral Glucose Tolerance Test and Continuous Glucose Monitoring | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Exchange Ratio | Respiratory Exchange Ratio will be used to quantify substrate utilization (fats vs carbohydrates) through the use of indirect calorimetry of in vivo gas exchange | 8 Weeks | 
| Amount of lean mass | Amount of lean mass will be measured by dual energy x-ray absortiometry | 8 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity