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NCT Number: NCT06722391

Neuromuscular Electrical Stimulation: A Novel Treatment for Improving Metabolism

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas at El Paso

El Paso, Texas, 79968, United States

Location status: Recruiting

Location contact

Jehu N Apaflo, MS

SUB_INVESTIGATOR

Sudip Bajpeyi, PhD

CONTACT

[email protected]

915-747-5461

Zahra Fatahimeiabadi, B.S.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuromuscular Electrical Stimulation (Sensory)

Device

Group will receive Electrical Stimulation up to sensory level

Other names: Control

Neuromuscular Electrical Stimulation

Device

Group will receive Electrical Stimulation up to maximum tolerable level

Other names: NMES Group

Resistance training

Other

Group will receive exercise training.

Other names: Control

Primary outcomes

  1. 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

Secondary outcomes

  1. Respiratory Exchange Ratio

    Time frame: 8 Weeks

    Respiratory Exchange Ratio will be used to quantify substrate utilization (fats vs carbohydrates) through the use of indirect calorimetry of in vivo gas exchange

  2. Amount of lean mass

    Time frame: 8 weeks

    Amount of lean mass will be measured by dual energy x-ray absortiometry

Study contacts

Contact information is provided by the study sponsor or research team.

Sudip Bajpeyi, PhD

CONTACT

[email protected]

9157475461

Sponsors and collaborators

Lead sponsor

University of Texas, El Paso

Other

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2031
First posted
Dec 9, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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