Improving Glycemic Control With Electrical Stimulation

NCT ID: NCT03947697

Last Updated: 2025-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-09

Study Completion Date

2027-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Overweight Insulin Resistance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Participants will receive stimulation only up to sensory level.

Group Type PLACEBO_COMPARATOR

Neuromuscular Electrical Stimulation (Sensory)

Intervention Type DEVICE

Group will receive Electrical Stimulation up to sensory level

NMES

Participants will receive stimulation up to maximum tolerable level.

Group Type EXPERIMENTAL

Neuromuscular Electrical Stimulation

Intervention Type DEVICE

Group will receive Electrical Stimulation up to maximum tolerable level

Resistance Training

Participants will receive exercise training with stimulation up to sensory level.

Group Type PLACEBO_COMPARATOR

Neuromuscular Electrical Stimulation (Sensory)

Intervention Type DEVICE

Group will receive Electrical Stimulation up to sensory level

Resistance Training

Intervention Type OTHER

Group will receive exercise training.

Resistance Training + NMES

Participants will receive exercise training with stimulation up to maximum tolerable intensity.

Group Type EXPERIMENTAL

Neuromuscular Electrical Stimulation

Intervention Type DEVICE

Group will receive Electrical Stimulation up to maximum tolerable level

Resistance Training

Intervention Type OTHER

Group will receive exercise training.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Neuromuscular Electrical Stimulation (Sensory)

Group will receive Electrical Stimulation up to sensory level

Intervention Type DEVICE

Neuromuscular Electrical Stimulation

Group will receive Electrical Stimulation up to maximum tolerable level

Intervention Type DEVICE

Resistance Training

Group will receive exercise training.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Control NMES Group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Texas, El Paso

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sudip Bajpeyi

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Texas at El Paso

El Paso, Texas, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sudip Bajpeyi, PhD

Role: CONTACT

9157475461

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sudip R Bajpeyi, PhD

Role: primary

9157475461

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 40721518 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1233722

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.