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RecruitingNCT06722391Updated Dec 9, 2024

Neuromuscular Electrical Stimulation: A Novel Treatment for Improving Metabolism

An interventional study of Neuromuscular Electrical Stimulation (Sensory) and Neuromuscular Electrical Stimulation in Insulin Resistance, sponsored by University of Texas, El Paso. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-09.

Sponsored by University of Texas, El Paso · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Aug 2024, registered Dec 2024).
  • Started Aug 2024; still recruiting 2 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Insulin Resistance

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Keywords

  • Neuromuscular Electrical Stimulation
  • Glucose Continuous Monitor
  • Blood Glucose
  • Obesity
  • Resting Metabolic rate
03

In context

Insulin Resistance

1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.

This study's planned enrollment of 80 is above the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.

Browse Insulin Resistance studies →

Lead sponsor

University of Texas, El Paso is the lead sponsor of 20 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Overweight/Obese (BMI ≥25)
  • Sedentary Lifestyle: Physical Activity Level\<1.4
  • Less than 150min/week of structured Exercise

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (estimated)

Study arms

  • Placebo comparator
    Control

    Participants will receive stimulation only up to sensory level.

    Device: Neuromuscular Electrical Stimulation (Sensory)

  • Experimental
    NMES

    Participants will receive stimulation up to maximum tolerable level.

    Device: Neuromuscular Electrical Stimulation

  • Placebo comparator
    Resistance Training

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

    Device: Neuromuscular Electrical Stimulation (Sensory) · Other: Resistance Training

  • Experimental
    Resistance Training + NMES

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

    Device: Neuromuscular Electrical Stimulation · Other: Resistance Training

Interventions

  • DeviceNeuromuscular Electrical Stimulation (Sensory)

    Group will receive Electrical Stimulation up to sensory level

    Also known as: Control

  • DeviceNeuromuscular Electrical Stimulation

    Group will receive Electrical Stimulation up to maximum tolerable level

    Also known as: NMES Group

  • OtherResistance Training

    Group will receive exercise training.

    Also known as: Control

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • University of Texas at El Paso
    El Paso, Texas 79968, United States
    • Sudip Bajpeyi, PhD · Contact · sbajpeyi@utep.edu · 915-747-5461
    • Zahra Fatahimeiabadi, B.S. · Sub investigator
    • Jehu N Apaflo, MS · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06722391
Lead sponsor
University of Texas, El Paso
Responsible party
Sudip Bajpeyi (Professor, University of Texas, El Paso) — Principal investigator
First posted
Dec 9, 2024
Start date
Aug 19, 2024
Primary completion
Sep 1, 2029 (estimated)
Completion
Sep 1, 2031 (estimated)
Last update
Dec 9, 2024

Study contacts

Sudip Bajpeyi, PhD
Contact
sbajpeyi@utep.edu
9157475461

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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