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Recruiting NCT06722391

Neuromuscular Electrical Stimulation: A Novel Treatment for Improving Metabolism

No phase Interventional Insulin Resistance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neuromuscular Electrical Stimulation (Sensory), Neuromuscular Electrical Stimulation, Resistance Training.
Who it may be relevant to
Registry conditions: Insulin Resistance. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Neuromuscular Electrical Stimulation (Sensory)
    Group will receive Electrical Stimulation up to sensory level
  • Device Neuromuscular Electrical Stimulation
    Group will receive Electrical Stimulation up to maximum tolerable level
  • Other Resistance Training
    Group will receive exercise training.

Primary outcome measures

  • Glycemic Control [Time frame: 8 weeks]
Secondary outcome measures (2)
  • Respiratory Exchange Ratio [Time frame: 8 Weeks]
  • Amount of lean mass [Time frame: 8 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Texas at El Paso — El Paso

Identifiers

NCT: NCT06722391 · 2205558

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗