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Improving Glycemic Control With Electrical Stimulation

NCT03947697 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-02-20

No results posted yet for this study

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=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.

Conditions

Interventions

DEVICE

Neuromuscular Electrical Stimulation (Sensory)

Group will receive Electrical Stimulation up to sensory level

DEVICE

Neuromuscular Electrical Stimulation

Group will receive Electrical Stimulation up to maximum tolerable level

OTHER

Resistance Training

Group will receive exercise training.

Sponsors & Collaborators

  • University of Texas, El Paso

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-09
Primary Completion
2026-11-25
Completion
2027-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03947697 on ClinicalTrials.gov