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
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