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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03947697
Other study ID # 1233722
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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