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A Novel Treatment Intervention for Improving Metabolism

Sponsor
University of Texas, El Paso (Other)
Overall Status
Recruiting
CT.gov ID
NCT03947697
Collaborator
(none)
60
Enrollment
1
Location
4
Arms
98.6
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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=15 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. Pre-and post-intervention data includes measurements for body composition, resting metabolic rate, VO2max, insulin sensitivity, and comprehensive blood work.

Condition or Disease Intervention/Treatment Phase
  • Device: Neuromuscular Electrical Stimulation (Sensory)
  • Device: Neuromuscular Electrical Stimulation
  • Other: Resistance Training
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Neuromuscular Electrical Stimulation: A Novel Treatment for Improving Metabolism
Actual Study Start Date :
Oct 12, 2018
Anticipated Primary Completion Date :
May 31, 2025
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

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.
    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.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. Amount of lean mass [8 Weeks]

      Amount of lean mass will be measured by dual energy x-ray absortiometry

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Texas at El Paso El Paso Texas United States 79968

    Sponsors and Collaborators

    • University of Texas, El Paso

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sudip Bajpeyi, Associate Professor, University of Texas, El Paso
    ClinicalTrials.gov Identifier:
    NCT03947697
    Other Study ID Numbers:
    • 1233722
    First Posted:
    May 13, 2019
    Last Update Posted:
    Jun 23, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Sudip Bajpeyi, Associate Professor, University of Texas, El Paso
    Obesity
    Additional relevant MeSH terms:
    Insulin Resistance
    Overweight

    Study Results

    No Results Posted as of Jun 23, 2022