Neuromuscular Electrical Stimulation: A Novel Treatment for Improving Metabolism

NCT06722391 | Recruiting FDA Device

• 1 other identifier: 2205558
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 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=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

Keywords

Neuromuscular Electrical Stimulation; Glucose Continuous Monitor; Blood Glucose; Obesity; Resting Metabolic rate

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 COMPARATOR

Participants will receive stimulation only up to sensory level.

Device: Neuromuscular Electrical Stimulation (Sensory)

NMES

EXPERIMENTAL

Participants will receive stimulation up to maximum tolerable level.

Device: Neuromuscular Electrical Stimulation

Resistance Training

PLACEBO COMPARATOR

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

Device: Neuromuscular Electrical Stimulation (Sensory); Other: Resistance Training

Resistance Training + NMES

EXPERIMENTAL

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

Device: Neuromuscular Electrical Stimulation; Other: Resistance Training

Interventions

Neuromuscular Electrical Stimulation (Sensory) DEVICE

Group will receive Electrical Stimulation up to sensory level

Also known as: Control

Control; Resistance Training

Neuromuscular Electrical Stimulation DEVICE

Group will receive Electrical Stimulation up to maximum tolerable level

Also known as: NMES Group

NMES; Resistance Training + NMES

Resistance Training OTHER

Group will receive exercise training.

Also known as: Control

Resistance Training; Resistance Training + NMES

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Texas, El Paso: lead

Study Sites (1)

University of Texas at El Paso

El Paso, Texas, 79968, United States

RECRUITING

MeSH Terms

Conditions

Insulin Resistance; Obesity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Sudip Bajpeyi, PhD

CONTACT

9157475461; sbajpeyi@utep.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 9, 2024
• Study Start: August 19, 2024
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2031
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)