Electrical Stimulation + Resistance Training for Insulin Resistance Due to Obesity
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Texas, El Paso
Must not be taking: Anti-hypertensives, Lipid-lowering, Insulin sensitizers
Disqualifiers: Alcohol, Drug abuse, Smoking, others
Trial Summary
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.
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.
12345Is 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.
12678How 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.
19101112Eligibility 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
+1 more
Trial 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
Participant Groups
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.
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Resistance Training + NMESExperimental Treatment2 Interventions
Participants will receive exercise training with stimulation up to maximum tolerable intensity.
Group II: NMESExperimental Treatment1 Intervention
Participants will receive stimulation up to maximum tolerable level.
Group III: ControlPlacebo Group1 Intervention
Participants will receive stimulation only up to sensory level.
Group IV: Resistance TrainingPlacebo Group2 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Texas at El PasoEl Paso, TX
Loading ...
Who Is Running the Clinical Trial?
University of Texas, El PasoLead Sponsor
References
Four weeks of electrical stimulation improves glucose tolerance in a sedentary overweight or obese Hispanic population. [2022]Most US adults (54%) do not meet the minimum exercise recommendations by the American College of Sports Medicine. Neuromuscular electrical stimulation (NMES) is a novel alternate strategy to induce muscle contraction. However, the effectiveness of NMES to improve insulin sensitivity and energy expenditure is unclear. The purpose of this study was to investigate the effects of 4 weeks of NMES on glucose tolerance in a sedentary overweight or obese population.
Comparison of maximum tolerated muscle torques produced by 2 pulse durations. [2014]Neuromuscular electrical stimulation (NMES) is an effective therapeutic technique for strengthening weak muscles. A positive dose-response relationship exists between the elicited muscle forces during training and strength (force-generating capacity) gains. Patient discomfort limits NMES muscle forces, potentially compromising efficacy.
Aerobic neuromuscular electrical stimulation--an emerging technology to improve haemoglobin A1c in type 2 diabetes mellitus: results of a pilot study. [2023]A new generation of neuromuscular electrical stimulation (NMES) devices can exercise aerobically at equivalent rates to voluntary exercise. Many with type 2 diabetes cannot or will not exercise sufficiently. The objective of this pilot investigation was to see (1) if it was an acceptable training modality for men with type 2 diabetes mellitus and (2) to assess effects on haemoglobin A1c levels.
Effects of neuromuscular electrical stimulation on glycemic control: a systematic review and meta-analysis. [2023]Physical inactivity increases the risk for metabolic diseases such as obesity and type 2 diabetes. Neuromuscular electrical stimulation (NMES) is an effective method to induce muscle contraction, particularly for populations with physical impairments and/or metabolic diseases. However, its effectiveness to improve glycemic control is unclear. This review aimed to determine the effectiveness of NMES on glycemic control.
Effect of Low Frequency Neuromuscular Electrical Stimulation on Glucose Profile of Persons with Type 2 Diabetes: A Pilot Study. [2018]The purpose of this study was to examine the effect of low-frequency neuromuscular electrical stimulation (NMES) on glucose profile in persons with type 2 diabetes mellitus (T2DM). Eight persons with T2DM (41 to 65 years) completed a glucose tolerance test with and without NMES delivered to the knee extensors for a 1-hour period at 8 Hz. Three blood samples were collected: at rest, and then 60 and 120 minutes after consumption of a glucose load on the NMES and control days. In NMES groups glucose concentrations were significantly lower (P
Long-term transcutaneous neuromuscular electrical stimulation in patients with bipolar sensing implantable cardioverter defibrillators: a pilot safety study. [2022]Neuromuscular electrical stimulation (NMES) is an option for increasing thigh muscle strength and endurance capacity in patients with chronic heart failure. Electromagnetic interference (EMI) by the signals with sensing of implantable cardioverter defibrillators (ICDs) is possible. The aim of the present pilot safety study was to test the safety of a long-term NMES in patients with ICDs. Six patients with subpectoral ICDs were subjected to long-term NMES of thigh muscles. Four inpatients received NMES to increase muscle strength, and two outpatients performed NMES as a home treatment to increase endurance capacity. During long-term NMES, all patients together received 14 139 799 biphasic electrical pulses and 412 425 on-phases without adverse events. ICD function after the stimulation period revealed no abnormalities in any patient. These results indicate that long-term NMES of thigh muscles seems to be safe in patients with ICDs, providing that an individual risk is excluded before.
Can the Use of Neuromuscular Electrical Stimulation Be Improved to Optimize Quadriceps Strengthening? [2019]Neuromuscular electrical stimulation (NMES) is a common modality used to retrain muscles and improve muscular strength after injury or surgery, particularly for the quadriceps muscle. There are parameter adjustments that can be made to maximize the effectiveness of NMES. While NMES is often used in clinical practice, there are some limitations that clinicians should be aware of, including patient discomfort, muscle fatigue, and muscle damage.
Effects of Neuromuscular Electrical Stimulation on Physiologic and Functional Measurements in Patients With Heart Failure: A SYSTEMATIC REVIEW WITH META-ANALYSIS. [2018]Neuromuscular electrical stimulation (NMES) is potentially attractive as a method of training in heart failure (HF) and could be performed in patients unable to participate in standard exercise training.
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]Skeletal muscle insulin resistance is a characteristic feature of type 2 diabetes. The aim of this study was to examine the effect of contraction on insulin action using electrical pulse stimulation (EPS) in cultured skeletal muscle cells from insulin resistant type 2 diabetic patients.
Electrical muscle stimulation acutely mimics exercise in neurologically intact individuals but has limited clinical benefits in patients with type 2 diabetes. [2013]Electrical muscle stimulation mimics exercise in individuals with neurological injury or disease and improves measures of fitness and glucose metabolism. Physical activity improves features of the metabolic syndrome in patients with type 2 diabetes but many patients find it difficult to exercise.
Visceral fat loss by whole-body electromyostimulation is attenuated in male and absent in female older Non-Insulin-Dependent diabetes patients. [2022]Type 2 diabetes and its reversal correlate with increases and decreases in visceral fat (VF). Resistance exercise reduces VF in healthy persons, but little is known in type 2 diabetes. Muscle contractions induced by whole-body electromyostimulation (WB-EMS) provide a very effective form of resistance training. We hypothesized that WB-EMS reduces VF and improves plasma glucose measures in older non-insulin dependent diabetes mellitus (NIDDM) males and females.
Electrical pulse stimulation induces differential responses in insulin action in myotubes from severely obese individuals. [2020]Label="KEY POINTS">Exercise/exercise training can enhance insulin sensitivity through adaptations in skeletal muscle, the primary site of insulin-mediated glucose disposal; however, in humans the range of improvement can vary substantially. The purpose of this study was to determine if obesity influences the magnitude of the exercise response in relation to improving insulin sensitivity in human skeletal muscle. Electrical pulse stimulation (EPS; 24 h) of primary human skeletal muscle myotubes improved insulin action in tissue from both lean and severely obese individuals, but responses to EPS were blunted with obesity. EPS improved insulin signal transduction in myotubes from lean but not severely obese subjects and increased AMP accumulation and AMPK Thr172 phosphorylation, but to a lesser degree in myotubes from the severely obese. These data reveal that myotubes of severely obese individuals enhance insulin action and stimulate exercise-responsive molecules with contraction, but in a manner and magnitude that differs from lean subjects.