Neuromuscular Electrical Stimulation: A Novel Treatment for Improving Metabolism

December 3, 2024 updated by: Sudip Bajpeyi, University of Texas, El Paso
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • El Paso, Texas, United States, 79968
        • Recruiting
        • University of Texas at El Paso
        • Contact:
        • Sub-Investigator:
          • Zahra Fatahimeiabadi, B.S.
        • Sub-Investigator:
          • Jehu N Apaflo, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Participants will receive stimulation only up to sensory level.
Device: Neuromuscular Electrical Stimulation (Sensory)
Group will receive Electrical Stimulation up to sensory level
Other Names:
  • Control
Experimental: NMES
Participants will receive stimulation up to maximum tolerable level.
Device: Neuromuscular Electrical Stimulation
Group will receive Electrical Stimulation up to maximum tolerable level
Other Names:
  • NMES Group
Placebo Comparator: Resistance Training
Participants will receive exercise training with stimulation up to sensory level.
Device: Neuromuscular Electrical Stimulation (Sensory)
Group will receive Electrical Stimulation up to sensory level
Other Names:
  • Control
Other: Resistance Training
Group will receive exercise training.
Other Names:
  • Control
Experimental: Resistance Training + NMES
Participants will receive exercise training with stimulation up to maximum tolerable intensity.
Device: Neuromuscular Electrical Stimulation
Group will receive Electrical Stimulation up to maximum tolerable level
Other Names:
  • NMES Group
Other: Resistance Training
Group will receive exercise training.
Other Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory Exchange Ratio
Time Frame: 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
8 Weeks
Amount of lean mass
Time Frame: 8 weeks
Amount of lean mass will be measured by dual energy x-ray absortiometry
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas, El Paso

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2024

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2031

Study Registration Dates

First Submitted

December 3, 2024

First Submitted That Met QC Criteria

December 3, 2024

First Posted (Estimated)

December 9, 2024

Study Record Updates

Last Update Posted (Estimated)

December 9, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2205558

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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