Improving Glycemic Control With Electrical Stimulation in Mexican-Americans

Obesity Clinical Trial

Official title:

Improving Glycemic Control With Electrical Stimulation in Mexican-Americans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03947697
• Other study ID #: 1233722
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2018
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2023
• Source: University of Texas, El Paso
• Contact: Sudip Bajpeyi, PhD
• Phone: 9157475461
• Email: sbajpeyi[@]utep.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2026
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity
• Overweight

Intervention

Device:
• Neuromuscular Electrical Stimulation (Sensory)
Group will receive Electrical Stimulation up to sensory level
• Neuromuscular Electrical Stimulation
Group will receive Electrical Stimulation up to maximum tolerable level

Other:
• Resistance Training
Group will receive exercise training.

Locations

Country	Name	City	State
United States	University of Texas at El Paso	El Paso	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas, El Paso

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic Control	Insulin Sensitivity will be measured through repeated blood sampling during an Oral Glucose Tolerance Test and Continuous Glucose Monitoring	8 weeks
Secondary	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	8 Weeks
Secondary	Amount of lean mass	Amount of lean mass will be measured by dual energy x-ray absortiometry	8 Weeks