Improving Glycemic Control with Electrical Stimulation

The University of Texas System (UT)

Status: Enrolling

Conditions: Overweight; Insulin Resistance; Obesity

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03947697

1233722

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 4 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Participants will receive stimulation only up to sensory level.

Treatment:

Device: Neuromuscular Electrical Stimulation (Sensory)

NMES

Experimental group

Description:

Participants will receive stimulation up to maximum tolerable level.

Treatment:

Device: Neuromuscular Electrical Stimulation

Resistance Training

Placebo Comparator group

Description:

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

Treatment:

Device: Neuromuscular Electrical Stimulation (Sensory)

Other: Resistance Training

Resistance Training + NMES

Experimental group

Description:

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

Treatment:

Other: Resistance Training

Device: Neuromuscular Electrical Stimulation