Neuromuscular Electrical Stimulation: A Novel Treatment for Improving Metabolism

Not Applicable

Recruiting

• Conditions: Insulin Resistance

• Registration Number: NCT06722391
• Lead Sponsor: University of Texas, El Paso

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-19
• Status Verified: 2024-12
• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09
• Primary Completion: 2029-09-01
• Study Completion: 2031-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Glycemic Control	8 weeks	Insulin Sensitivity will be measured through repeated blood sampling during an Oral Glucose Tolerance Test and Continuous Glucose Monitoring

Secondary Outcome Measures

Name	Time	Method
Respiratory Exchange Ratio	8 Weeks	Respiratory Exchange Ratio will be used to quantify substrate utilization (fats vs carbohydrates) through the use of indirect calorimetry of in vivo gas exchange
Amount of lean mass	8 weeks	Amount of lean mass will be measured by dual energy x-ray absortiometry

Trial Locations

Locations (1)

University of Texas at El Paso; 🇺🇸 El Paso, Texas, United States