Improving Glycemic Control With Electrical Stimulation in Mexican-Americans
Primary Purpose
Obesity, Overweight, Insulin Resistance
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neuromuscular Electrical Stimulation (Sensory)
Neuromuscular Electrical Stimulation
Resistance Training
Sponsored by
About this trial
This is an interventional basic science trial for Obesity focused on measuring Obesity
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
Sites / Locations
- University of Texas at El PasoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Arm Label
Control
NMES
Resistance Training
Resistance Training + NMES
Arm Description
Participants will receive stimulation only up to sensory level.
Participants will receive stimulation up to maximum tolerable level.
Participants will receive exercise training with stimulation up to sensory level.
Participants will receive exercise training with stimulation up to maximum tolerable intensity.
Outcomes
Primary Outcome Measures
Glycemic Control
Insulin Sensitivity will be measured through repeated blood sampling during an Oral Glucose Tolerance Test and Continuous Glucose Monitoring
Secondary Outcome Measures
Respiratory Exchange Ratio
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
Amount of lean mass will be measured by dual energy x-ray absortiometry
Full Information
NCT ID
NCT03947697
First Posted
December 7, 2018
Last Updated
April 26, 2023
Sponsor
University of Texas, El Paso
1. Study Identification
Unique Protocol Identification Number
NCT03947697
Brief Title
Improving Glycemic Control With Electrical Stimulation in Mexican-Americans
Official Title
Improving Glycemic Control With Electrical Stimulation in Mexican-Americans
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2018 (Actual)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas, El Paso
4. Oversight
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
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight, Insulin Resistance
Keywords
Obesity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Participants will receive stimulation only up to sensory level.
Arm Title
NMES
Arm Type
Experimental
Arm Description
Participants will receive stimulation up to maximum tolerable level.
Arm Title
Resistance Training
Arm Type
Placebo Comparator
Arm Description
Participants will receive exercise training with stimulation up to sensory level.
Arm Title
Resistance Training + NMES
Arm Type
Experimental
Arm Description
Participants will receive exercise training with stimulation up to maximum tolerable intensity.
Intervention Type
Device
Intervention Name(s)
Neuromuscular Electrical Stimulation (Sensory)
Other Intervention Name(s)
Control
Intervention Description
Group will receive Electrical Stimulation up to sensory level
Intervention Type
Device
Intervention Name(s)
Neuromuscular Electrical Stimulation
Other Intervention Name(s)
NMES Group
Intervention Description
Group will receive Electrical Stimulation up to maximum tolerable level
Intervention Type
Other
Intervention Name(s)
Resistance Training
Intervention Description
Group will receive exercise training.
Primary Outcome Measure Information:
Title
Glycemic Control
Description
Insulin Sensitivity will be measured through repeated blood sampling during an Oral Glucose Tolerance Test and Continuous Glucose Monitoring
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Respiratory Exchange Ratio
Description
Respiratory Exchange Ratio will be used to quantify substrate utilization (fats vs carbohydrates) through the use of indirect calorimetry of in vivo gas exchange
Time Frame
8 Weeks
Title
Amount of lean mass
Description
Amount of lean mass will be measured by dual energy x-ray absortiometry
Time Frame
8 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sudip Bajpeyi, PhD
Phone
9157475461
Email
sbajpeyi@utep.edu
Facility Information:
Facility Name
University of Texas at El Paso
City
El Paso
State/Province
Texas
ZIP/Postal Code
79968
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sudip R Bajpeyi, PhD
Phone
915-747-5461
Email
sbajpeyi@utep.edu
First Name & Middle Initial & Last Name & Degree
Michelle Galvan, B.S.
First Name & Middle Initial & Last Name & Degree
Jehu N Apaflo, M.S.
First Name & Middle Initial & Last Name & Degree
Gabriel Narvaez, B.S.
12. IPD Sharing Statement
Plan to Share IPD
No
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Improving Glycemic Control With Electrical Stimulation in Mexican-Americans
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