Improving Glycemic Control With Electrical Stimulation
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Aug 2022
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2018
CompletedFirst Posted
Study publicly available on registry
May 13, 2019
CompletedStudy Start
First participant enrolled
August 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 25, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2027
February 20, 2025
August 1, 2024
4.3 years
December 7, 2018
February 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glycemic Control
Insulin Sensitivity will be measured through repeated blood sampling during an Oral Glucose Tolerance Test and Continuous Glucose Monitoring
8 weeks
Secondary Outcomes (2)
Respiratory Exchange Ratio
8 Weeks
Amount of lean mass
8 Weeks
Study Arms (4)
Control
PLACEBO COMPARATORParticipants will receive stimulation only up to sensory level.
NMES
EXPERIMENTALParticipants will receive stimulation up to maximum tolerable level.
Resistance Training
PLACEBO COMPARATORParticipants will receive exercise training with stimulation up to sensory level.
Resistance Training + NMES
EXPERIMENTALParticipants will receive exercise training with stimulation up to maximum tolerable intensity.
Interventions
Group will receive Electrical Stimulation up to sensory level
Group will receive Electrical Stimulation up to maximum tolerable level
Group will receive exercise training.
Eligibility Criteria
You may qualify if:
- Overweight/Obese (BMI ≥25)
- Sedentary Lifestyle: Physical Activity Level\<1.4
- Less than 150min/week of structured Exercise
You may not qualify if:
- Use of anti-hypertensive, lipid-lowering or insulin sensitizing medications
- Excessive alcohol, drug abuse, smoking
- Pregnant Women
- Unwilling to adhere to the study Intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas at El Paso
El Paso, Texas, 79968, United States
Related Publications (1)
Apaflo JN, Narvaez G, Tomy IJ, Mossayebi A, Fatahimeiabadi Z, McAinch AJ, Thyfault JP, Min K, Jung H, Wagler AE, Bajpeyi S. Neuromuscular electrical stimulation enhances glycemic control and carbohydrate utilization in sedentary, predominantly Hispanic overweight or obese individuals with hyperglycemia. Eur J Appl Physiol. 2025 Jul 28. doi: 10.1007/s00421-025-05907-x. Online ahead of print.
PMID: 40721518DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 7, 2018
First Posted
May 13, 2019
Study Start
August 9, 2022
Primary Completion (Estimated)
November 25, 2026
Study Completion (Estimated)
April 30, 2027
Last Updated
February 20, 2025
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share