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Clinical Trials/NCT06722391
NCT06722391
Recruiting
Not Applicable

Neuromuscular Electrical Stimulation: A Novel Treatment for Improving Metabolism

University of Texas, El Paso1 site in 1 country80 target enrollmentAugust 19, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Insulin Resistance
Sponsor
University of Texas, El Paso
Enrollment
80
Locations
1
Primary Endpoint
Glycemic Control
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 19, 2024
End Date
September 1, 2031
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Texas, El Paso
Responsible Party
Principal Investigator
Principal Investigator

Sudip Bajpeyi

Professor

University of Texas, El Paso

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

Outcomes

Primary Outcomes

Glycemic Control

Time Frame: 8 weeks

Insulin Sensitivity will be measured through repeated blood sampling during an Oral Glucose Tolerance Test and Continuous Glucose Monitoring

Secondary Outcomes

  • Amount of lean mass(8 weeks)
  • Respiratory Exchange Ratio(8 Weeks)

Study Sites (1)

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