Neuromuscular Electrical Stimulation: A Novel Treatment for Improving Metabolism

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Texas, El Paso

About this trial

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=20 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. Control and NMES group will self administer stimulation at home. Pre-and post-intervention data includes measurements for body composition, resting metabolic rate, VO2max, insulin sensitivity, and comprehensive blood work.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Overweight/Obese (BMI ≥25)

Sedentary Lifestyle: Physical Activity Level<1.4

Less than 150min/week of structured Exercise

Disqualifiers

Use of anti-hypertensive, lipid-lowering or insulin sensitizing medications

Excessive alcohol, drug abuse, smoking

Pregnant Women

Unwilling to adhere to the study Intervention

Trial design

Design model

Parallel

Treatments tested in this trial

  • Neuromuscular Electrical Stimulation (Sensory)

    Device

    Group will receive Electrical Stimulation up to sensory level

  • Neuromuscular Electrical Stimulation

    Device

    Group will receive Electrical Stimulation up to maximum tolerable level

  • Resistance Training

    Other intervention

    Group will receive exercise training.

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: ControlPlacebo comparator 1 intervention
Group B: NMESExperimental treatment 1 intervention
Group C: Resistance TrainingPlacebo comparator 2 interventions
Group D: Resistance Training + NMESExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Glycemic Control

Insulin Sensitivity will be measured through repeated blood sampling during an Oral Glucose Tolerance Test and Continuous Glucose Monitoring

Time frame
8 weeks

Secondary outcomes

1

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

Time frame
8 Weeks
2

Amount of lean mass

Amount of lean mass will be measured by dual energy x-ray absortiometry

Time frame
8 weeks

Other outcomes

Sponsors and contacts

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