Neuromuscular Electrical Stimulation: A Novel Treatment for Improving Metabolism

Part of paid clinical trials in El Paso, Texas.

Sponsor
University of Texas, El Paso
Study ID
NCT06722391
Status
Recruiting
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Conditions

  • Insulin Resistance

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • 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
    Group will receive exercise training.

Study Details

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.

Key Dates

Start date
Aug 19, 2024
Status verified
Dec 2024
Primary completion
Sep 1, 2029
Completion
Sep 1, 2031

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Placebo Comparator: Control
    Participants will receive stimulation only up to sensory level.
  • Experimental: NMES
    Participants will receive stimulation up to maximum tolerable level.
  • Placebo Comparator: Resistance Training
    Participants will receive exercise training with stimulation up to sensory level.
  • Experimental: Resistance Training + NMES
    Participants will receive exercise training with stimulation up to maximum tolerable intensity.

Primary Outcome Measure

Glycemic Control [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas at El PasoEl PasoTexas79968
Sudip Bajpeyi, PhD
[email protected]
915-747-5461
Zahra Fatahimeiabadi, B.S. (SUB_INVESTIGATOR)
Jehu N Apaflo, MS (SUB_INVESTIGATOR)

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