Recruiting

Neuromuscular Electrical Stimulation

Sponsor:

University of Texas, El Paso

Code:

NCT06722391

Conditions

Insulin Resistance

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Neuromuscular Electrical Stimulation (Sensory)

Neuromuscular Electrical Stimulation

Resistance Training

Study Details

Brief 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.

Conditions

Insulin Resistance

Study ID

NCT06722391

Start date

Aug 19, 2024

Status verified date

Dec, 2024

Completion date

Sep 1, 2031

Anticipated

Primary completion date

Sep 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Neuromuscular Electrical Stimulation (Sensory)

Group will receive Electrical Stimulation up to sensory level

Neuromuscular Electrical Stimulation

Group will receive Electrical Stimulation up to maximum tolerable level

Resistance Training

Group will receive exercise training.

Primary outcome measure

  • Glycemic Control [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Locations

University of Texas at El Paso

Recruiting

El Paso, Texas, United States, 79968

Contacts

More Information

Sponsor

University of Texas, El Paso

Last update posted

Dec 9, 2024

Last verified

Dec, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-16. This information was provided to ClinicalTrials.gov by University of Texas, El Paso on 2024-12-09.