Electrical Stimulation + Resistance Training for Insulin Resistance Due to Obesity

Overseen By Sudip Bajpeyi, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas, El Paso

Must not be taking: Anti-hypertensives, Lipid-lowering, Insulin sensitizers

Disqualifiers: Alcohol, Drug abuse, Smoking, others

Compensation: Varies

Number of Visits: 27

Duration: 8 weeks

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, you will need to stop taking any anti-hypertensive, lipid-lowering, or insulin sensitizing medications to participate in this trial.

What data supports the effectiveness of this treatment for insulin resistance due to obesity?

Research shows that neuromuscular electrical stimulation (NMES) can improve glucose tolerance in overweight or obese individuals and may help manage blood sugar levels in people with type 2 diabetes, suggesting potential benefits for insulin resistance. ^{1 2 3 4 5}

Is electrical stimulation safe for humans?

Research shows that long-term use of neuromuscular electrical stimulation (NMES) is generally safe, even in patients with heart devices, as no adverse events were reported in studies. However, some people may experience discomfort, muscle fatigue, or muscle damage. ^{1 2 6 7 8}

How does the treatment of electrical stimulation and resistance training for insulin resistance due to obesity differ from other treatments?

This treatment is unique because it combines neuromuscular electrical stimulation (NMES) with resistance training to mimic the effects of exercise, which can be challenging for many patients with obesity. Unlike traditional exercise, NMES induces muscle contractions without physical activity, potentially improving insulin sensitivity and glucose metabolism in those who struggle to meet exercise recommendations. ^{1 9 10 11 12}

What is the purpose of 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=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.

Eligibility Criteria

This trial is for Mexican-Americans who are overweight or obese, have a sedentary lifestyle with less than 150 minutes of exercise per week, and do not use certain medications. Smokers, pregnant women, and those unwilling to follow the study plan cannot participate.

Inclusion Criteria

You weigh more than what is considered healthy for your height.

You don't engage in much physical activity, with a physical activity level below 1.4.

You do less than 150 minutes of planned exercise each week.

Exclusion Criteria

I am taking medication for high blood pressure, cholesterol, or to help my body use insulin better.

Unwilling to adhere to the study Intervention

Pregnant Women

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Pre-intervention

Participants wear an accelerometer for 7 days and follow a standardized diet to assess physical activity and collect pre-intervention data

1 week

1 visit (in-person)

Treatment

Participants undergo an 8-week electrical stimulation intervention, randomized into different groups for NMES and resistance training

8 weeks

24 sessions (in-person, 3x/week)

Post-intervention

Collection of post-intervention data including body composition, metabolic rate, VO2max, insulin sensitivity, and blood work

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Neuromuscular Electrical Stimulation
• Neuromuscular Electrical Stimulation (Sensory)
• Resistance Training

Trial Overview The study tests how well electrical stimulation combined with resistance training improves insulin sensitivity in participants. They'll be randomly assigned to one of four groups: control (sensory-level stimulation), NMES (visible muscle contraction), RT+NMES (stimulation during resistance training), or just resistance training.

Participant Groups

Group I: Resistance Training + NMES Experimental Treatment 2 Interventions

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

Group II: NMES Experimental Treatment 1 Intervention

Participants will receive stimulation up to maximum tolerable level.

Group III: Control Placebo Group 1 Intervention

Participants will receive stimulation only up to sensory level.

Group IV: Resistance Training Placebo Group 2 Interventions

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

Neuromuscular Electrical Stimulation is already approved in United States, European Union for the following indications:

Approved in United States as NMES for:

• Improving glycemic control in individuals with type 2 diabetes and obesity

Approved in European Union as Electrical Muscle Stimulation for:

• Management of type 2 diabetes
• Improvement of insulin sensitivity

Who Is Running the Clinical Trial?

University of Texas, El Paso

Lead Sponsor

Trials

17

Recruited

3,000+

Findings from Research

A 4-week study involving 10 sedentary overweight or obese adults showed that neuromuscular electrical stimulation (NMES) significantly improved glucose tolerance compared to a control group, indicating its potential as an effective intervention for metabolic health.

Despite the improvements in glucose tolerance, NMES did not result in changes in substrate utilization or muscle mass, suggesting that while NMES can enhance metabolic function, it may not directly increase muscle size or energy expenditure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Four weeks of electrical stimulation improves glucose tolerance in a sedentary overweight or obese Hispanic population. Galvan, MJ., Sanchez, MJ., McAinch, AJ., et al.[2022]

In a study involving 10 adults, neuromuscular electrical stimulation (NMES) with a 200-microsecond pulse duration allowed participants to tolerate significantly greater muscle torques compared to a 50-microsecond pulse duration, indicating enhanced efficacy for muscle strengthening.

The findings suggest that medium pulse durations may be more effective for maximizing muscle torque responses, despite the common belief that shorter pulses are preferable due to lower pain thresholds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of maximum tolerated muscle torques produced by 2 pulse durations. Scott, WB., Causey, JB., Marshall, TL.[2014]

A pilot study involving eight men with type 2 diabetes showed that using a new neuromuscular electrical stimulation (NMES) device for 1 hour, six times a week, significantly improved their hemoglobin A1c levels by 0.8%, indicating better blood sugar control.

Participants found the NMES system effective and suitable for people with diabetes, suggesting it could be a valuable alternative for those unable or unwilling to engage in traditional exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic neuromuscular electrical stimulation--an emerging technology to improve haemoglobin A1c in type 2 diabetes mellitus: results of a pilot study. Crowe, L., Caulfield, B.[2023]

A systematic review of 35 studies, including a meta-analysis of 9 randomized controlled trials with 180 participants, found that neuromuscular electrical stimulation (NMES) significantly lowers fasting blood glucose levels, indicating its effectiveness in improving glycemic control, especially in middle-aged and elderly individuals with type 2 diabetes and obesity.

The results suggest that NMES could be a beneficial therapeutic strategy for enhancing glycemic control in populations with physical impairments or metabolic disorders, although the protocols used in the studies varied and need standardization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of neuromuscular electrical stimulation on glycemic control: a systematic review and meta-analysis. Sanchez, MJ., Mossayebi, A., Sigaroodi, S., et al.[2023]

In a study involving 8 individuals with type 2 diabetes, low-frequency neuromuscular electrical stimulation (NMES) significantly reduced glucose levels after a glucose load compared to control conditions, indicating its potential efficacy in managing blood sugar levels.

The results also showed a strong positive correlation between the intensity of NMES and the reduction in blood glucose, suggesting that higher stimulation intensity may enhance glucose uptake in individuals with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Low Frequency Neuromuscular Electrical Stimulation on Glucose Profile of Persons with Type 2 Diabetes: A Pilot Study. Jabbour, G., Belliveau, L., Probizanski, D., et al.[2018]

A pilot safety study involving six patients with implantable cardioverter defibrillators (ICDs) showed that long-term neuromuscular electrical stimulation (NMES) of thigh muscles is safe, with no adverse events reported during the treatment.

All patients received a total of over 14 million electrical pulses without any abnormalities in ICD function, suggesting that NMES can be a viable option for improving muscle strength and endurance in patients with chronic heart failure who have ICDs, provided individual risks are assessed beforehand.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term transcutaneous neuromuscular electrical stimulation in patients with bipolar sensing implantable cardioverter defibrillators: a pilot safety study. Crevenna, R., Wolzt, M., Fialka-Moser, V., et al.[2022]

Neuromuscular electrical stimulation (NMES) can effectively retrain muscles and improve strength, particularly in the quadriceps, by adjusting parameters like pulse duration (400 to 600 μs) and pulse frequency (30 to 50 Hz) to optimize torque production while minimizing discomfort and fatigue.

Clinicians should consider optimal electrode placement and conditioning programs to further enhance the effectiveness of NMES, ensuring better patient outcomes during rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can the Use of Neuromuscular Electrical Stimulation Be Improved to Optimize Quadriceps Strengthening? Glaviano, NR., Saliba, S.[2019]

Neuromuscular electrical stimulation (NMES) significantly improved various health metrics in heart failure patients, including peak oxygen uptake, 6-minute walk test distance, muscle strength, and quality of life, based on a review of 13 studies.

The results suggest that NMES can be an effective alternative for patients unable to participate in traditional exercise training, showing comparable benefits to exercise in improving functional and physiological outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Neuromuscular Electrical Stimulation on Physiologic and Functional Measurements in Patients With Heart Failure: A SYSTEMATIC REVIEW WITH META-ANALYSIS. Gomes Neto, M., Oliveira, FA., Reis, HF., et al.[2018]

Electrical pulse stimulation (EPS) enhances insulin action on glucose uptake and AS160 phosphorylation in skeletal muscle cells from non-diabetic individuals, mimicking the metabolic benefits of exercise.

In contrast, while EPS activates AMPK similarly in both diabetic and non-diabetic muscle cells, the insulin response for glucose uptake and AS160 phosphorylation is significantly impaired in diabetic cells, highlighting a key difference in insulin resistance mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impaired enhancement of insulin action in cultured skeletal muscle cells from insulin resistant type 2 diabetic patients in response to contraction using electrical pulse stimulation. Al-Bayati, A., Brown, A., Walker, M.[2021]

The electrical muscle stimulator was found to acutely increase pulse, blood pressure, energy expenditure, and glucose uptake in healthy individuals, suggesting it can mimic some effects of exercise.

However, after 12 weeks of daily use in patients with type 2 diabetes, while there were improvements in insulin sensitivity, there were no significant changes in body composition or clinical parameters, indicating that the current stimulation levels may not be sufficient for substantial clinical benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical muscle stimulation acutely mimics exercise in neurologically intact individuals but has limited clinical benefits in patients with type 2 diabetes. Poole, RB., Harrold, CP., Burridge, JH., et al.[2013]

Whole-body electromyostimulation (WB-EMS) significantly reduced visceral fat in healthy older males and females, with reductions of approximately 16% compared to baseline, indicating its efficacy as a resistance training method.

In older non-insulin dependent diabetes mellitus (NIDDM) patients, WB-EMS led to only a modest 7.3% reduction in visceral fat in males, while no significant fat loss was observed in females, suggesting that sex differences may influence the effectiveness of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visceral fat loss by whole-body electromyostimulation is attenuated in male and absent in female older Non-Insulin-Dependent diabetes patients. Houdijk, APJ., Bos, NFJME., Verduin, WM., et al.[2022]

Electrical pulse stimulation (EPS) improved insulin action in skeletal muscle cells from both lean and severely obese individuals, but the response was significantly weaker in those who were severely obese, indicating that obesity blunts the effectiveness of exercise on insulin sensitivity.

Despite the reduced response, EPS still stimulated important molecules related to insulin action and exercise in severely obese individuals, suggesting that while they can benefit from exercise, the improvements are not as pronounced as in lean individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical pulse stimulation induces differential responses in insulin action in myotubes from severely obese individuals. Park, S., Turner, KD., Zheng, D., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Four weeks of electrical stimulation improves glucose tolerance in a sedentary overweight or obese Hispanic population. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Comparison of maximum tolerated muscle torques produced by 2 pulse durations. [2014]

3. England pubmed.ncbi.nlm.nih.gov

Aerobic neuromuscular electrical stimulation--an emerging technology to improve haemoglobin A1c in type 2 diabetes mellitus: results of a pilot study. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of neuromuscular electrical stimulation on glycemic control: a systematic review and meta-analysis. [2023]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Effect of Low Frequency Neuromuscular Electrical Stimulation on Glucose Profile of Persons with Type 2 Diabetes: A Pilot Study. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Long-term transcutaneous neuromuscular electrical stimulation in patients with bipolar sensing implantable cardioverter defibrillators: a pilot safety study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Can the Use of Neuromuscular Electrical Stimulation Be Improved to Optimize Quadriceps Strengthening? [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of Neuromuscular Electrical Stimulation on Physiologic and Functional Measurements in Patients With Heart Failure: A SYSTEMATIC REVIEW WITH META-ANALYSIS. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Impaired enhancement of insulin action in cultured skeletal muscle cells from insulin resistant type 2 diabetic patients in response to contraction using electrical pulse stimulation. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Electrical muscle stimulation acutely mimics exercise in neurologically intact individuals but has limited clinical benefits in patients with type 2 diabetes. [2013]

11. England pubmed.ncbi.nlm.nih.gov

Visceral fat loss by whole-body electromyostimulation is attenuated in male and absent in female older Non-Insulin-Dependent diabetes patients. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Electrical pulse stimulation induces differential responses in insulin action in myotubes from severely obese individuals. [2020]