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A Novel Treatment Intervention for Improving Metabolism

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ClinicalTrials.gov Identifier: NCT03947697
Recruitment Status : Recruiting
First Posted : May 13, 2019
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Sudip Bajpeyi, 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=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
Obesity Overweight Insulin Resistance Device: Neuromuscular Electrical Stimulation (Sensory) Device: Neuromuscular Electrical Stimulation Other: Resistance Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 12, 2018
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : December 31, 2020

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 Name: 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 Name: 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 Name: 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 Name: NMES Group

Other: Resistance Training
Group will receive exercise training.




Primary Outcome Measures :
  1. Oral Glucose Tolerance Test [ Time Frame: 8 weeks ]
    Insulin Sensitivity will be measured through repeated blood sampling during an Oral Glucose Tolerance Test


Secondary Outcome Measures :
  1. 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

  2. Amount of lean mass [ Time Frame: 8 Weeks ]
    Amount of lean mass will be measured by dual energy x-ray absortiometry



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03947697


Contacts
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Contact: Sudip Bajpeyi, PhD 9157475461 sbajpeyi@utep.edu

Locations
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United States, Texas
University of Texas at El Paso Recruiting
El Paso, Texas, United States, 79968
Contact: Sudip R Bajpeyi, PhD    915-747-5461    sbajpeyi@utep.edu   
Sub-Investigator: Jasmin Jenkins, B.S.         
Sub-Investigator: Michelle Galvan, B.S.         
Sponsors and Collaborators
University of Texas, El Paso

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Responsible Party: Sudip Bajpeyi, Associate Professor, University of Texas, El Paso
ClinicalTrials.gov Identifier: NCT03947697     History of Changes
Other Study ID Numbers: 1233722
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Sudip Bajpeyi, University of Texas, El Paso:
Obesity

Additional relevant MeSH terms:
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Overweight
Insulin Resistance
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases