Insulin ResistanceNCT06722391
Neuromuscular Electrical Stimulation: A Novel Treatment for Improving Metabolism
A study testing Neuromuscular Electrical Stimulation (Sensory), Neuromuscular Electrical Stimulation and Resistance Training in people with Insulin Resistance, run by University of Texas, El Paso at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Neuromuscular Electrical Stimulation (Sensory), Neuromuscular Electrical Stimulation and Resistance Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2024to 1 Sep 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overweight/Obese (BMI ≥25)
- Sedentary Lifestyle: Physical Activity Level\<1.4
- Less than 150min/week of structured Exercise
Who cannot join
- Use of anti-hypertensive, lipid-lowering or insulin sensitizing medications
- Excessive alcohol, drug abuse, smoking
- Pregnant Women
- Unwilling to adhere to the study Intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas at El Paso
El Paso, Texas, 79968
Sudip Bajpeyi, PhD, 9157475461, sbajpeyi@utep.edu
Zahra Fatahimeiabadi, B.S.
About this study
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=20 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. Control and NMES group will self administer stimulation at home. Pre-and post-intervention data includes measurements for body composition, resting metabolic rate, VO2max, insulin sensitivity, and comprehensive blood work.
- Conditions
- Insulin Resistance
- Being tested
- Neuromuscular Electrical Stimulation (Sensory), Neuromuscular Electrical Stimulation, Resistance Training
- Keywords
- Neuromuscular Electrical Stimulation, Glucose Continuous Monitor, Blood Glucose, Obesity, Resting Metabolic rate
- Medical subject headings
- Insulin Resistance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Electrical Stimulation (Sensory)Device
Also called Control
Group will receive Electrical Stimulation up to sensory level
Neuromuscular Electrical StimulationDevice
Also called NMES Group
Group will receive Electrical Stimulation up to maximum tolerable level
Resistance TrainingOther
Also called Control
Group will receive exercise training.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Participants will receive stimulation only up to sensory level. Receives: Device: Neuromuscular Electrical Stimulation (Sensory) |
| NMES | Experimental | Participants will receive stimulation up to maximum tolerable level. Receives: Device: Neuromuscular Electrical Stimulation |
| Resistance Training | Placebo comparator | Participants will receive exercise training with stimulation up to sensory level. Receives: Device: Neuromuscular Electrical Stimulation (Sensory); Other: Resistance Training |
| Resistance Training + NMES | Experimental | Participants will receive exercise training with stimulation up to maximum tolerable intensity. Receives: Device: Neuromuscular Electrical Stimulation; Other: Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Control
Insulin Sensitivity will be measured through repeated blood sampling during an Oral Glucose Tolerance Test and Continuous Glucose Monitoring
Measured: 8 weeks
Secondary outcomes (2)
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
Measured: 8 Weeks
Amount of lean mass
Amount of lean mass will be measured by dual energy x-ray absortiometry
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start19 Aug 2024
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas, El Paso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sudip Bajpeyi, University of Texas, El Paso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722391
- Sponsor's protocol ID
- 2205558
- Status last verified
- Oct 2026
- First submitted
- 3 Dec 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Electrical Stimulation: A Novel Treatment for Improving Metabolism
- ClinicalTrials.gov ID
- NCT06722391
- Acronym / sponsor ID
- 2205558
- Conditions
- Insulin Resistance
- Keywords
- Neuromuscular Electrical Stimulation, Glucose Continuous Monitor, Blood Glucose, Obesity, Resting Metabolic rate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Texas, El PasoUniversity, hospital or other
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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=20 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. Control and NMES group will self administer stimulation at home. Pre-and post-intervention data includes measurements for body composition, resting metabolic rate, VO2max, insulin sensitivity, and comprehensive blood work.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Device: Neuromuscular Electrical Stimulation (Sensory)Participants will receive stimulation only up to sensory level. |
| NMES | Experimental | Device: Neuromuscular Electrical StimulationParticipants will receive stimulation up to maximum tolerable level. |
| Resistance Training | Placebo comparator | Device: Neuromuscular Electrical Stimulation (Sensory), Other: Resistance TrainingParticipants will receive exercise training with stimulation up to sensory level. |
| Resistance Training + NMES | Experimental | Device: Neuromuscular Electrical Stimulation, Other: Resistance TrainingParticipants will receive exercise training with stimulation up to maximum tolerable intensity. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Overweight/Obese (BMI ≥25)
- Sedentary Lifestyle: Physical Activity Level\<1.4
- Less than 150min/week of structured Exercise
Key exclusion criteria (4 listed)
- Use of anti-hypertensive, lipid-lowering or insulin sensitizing medications
- Excessive alcohol, drug abuse, smoking
- Pregnant Women
- Unwilling to adhere to the study Intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular Electrical Stimulation (Sensory)Also: ControlGroup will receive Electrical Stimulation up to sensory level | Device | Control, Resistance Training |
| Neuromuscular Electrical StimulationAlso: NMES GroupGroup will receive Electrical Stimulation up to maximum tolerable level | Device | NMES, Resistance Training + NMES |
| Resistance TrainingAlso: ControlGroup will receive exercise training. | Other | Resistance Training, Resistance Training + NMES |
Primary outcome
Glycemic Control
Time frame: 8 weeks
Insulin Sensitivity will be measured through repeated blood sampling during an Oral Glucose Tolerance Test and Continuous Glucose Monitoring
2 secondary outcomes
Respiratory Exchange Ratio
Time frame: 8 Weeks
Amount of lean mass
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Insulin Resistance
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Electrical Stimulation (Sensory), Neuromuscular Electrical Stimulation and Resistance Training in people with Insulin Resistance, run by University of Texas, El Paso at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sudip Bajpeyi, PhD (9157475461, sbajpeyi@utep.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Control (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.