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Electrical Stimulation
Electrical Stimulation + Resistance Training for Insulin Resistance Due to Obesity
N/A
Recruiting
Research Sponsored by University of Texas, El Paso
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Study Summary
This trial will study the effects of electrical stimulation and resistance training on insulin sensitivity in obese individuals.
Who is the study for?
This trial is for Mexican-Americans who are overweight or obese, have a sedentary lifestyle with less than 150 minutes of exercise per week, and do not use certain medications. Smokers, pregnant women, and those unwilling to follow the study plan cannot participate.Check my eligibility
What is being tested?
The study tests how well electrical stimulation combined with resistance training improves insulin sensitivity in participants. They'll be randomly assigned to one of four groups: control (sensory-level stimulation), NMES (visible muscle contraction), RT+NMES (stimulation during resistance training), or just resistance training.See study design
What are the potential side effects?
Possible side effects from the interventions may include discomfort at the stimulation site, muscle soreness similar to after exercising, skin irritation from electrodes or equipment used during sessions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Glycemic Control
Secondary outcome measures
Amount of lean mass
Respiratory Exchange Ratio
Side effects data
From 2010 Phase 2 trial • 167 Patients • NCT0011215166%
Other noncardiovascular serious adverse events
13%
Other nonserious adverse events
11%
Persistently elevated PSA
4%
Total serious cardiovascular adverse events
4%
Persistently elevated HCT >= 54%
2%
Elevated AUA
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Lower-range T
Higher-range T
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Resistance Training + NMESExperimental Treatment2 Interventions
Participants will receive exercise training with stimulation up to maximum tolerable intensity.
Group II: NMESExperimental Treatment1 Intervention
Participants will receive stimulation up to maximum tolerable level.
Group III: ControlPlacebo Group1 Intervention
Participants will receive stimulation only up to sensory level.
Group IV: Resistance TrainingPlacebo Group2 Interventions
Participants will receive exercise training with stimulation up to sensory level.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Neuromuscular Electrical Stimulation
2014
N/A
~430
Find a Location
Who is running the clinical trial?
University of Texas, El PasoLead Sponsor
13 Previous Clinical Trials
2,633 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking medication for high blood pressure, cholesterol, or to help my body use insulin better.You use a lot of alcohol or drugs, or you smoke heavily.You weigh more than what is considered healthy for your height.You don't engage in much physical activity, with a physical activity level below 1.4.You do less than 150 minutes of planned exercise each week.
Research Study Groups:
This trial has the following groups:- Group 1: Resistance Training + NMES
- Group 2: Control
- Group 3: NMES
- Group 4: Resistance Training
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still slots available for participants of this investigation?
"Clinicaltrials.gov lists this trial as actively enrolling participants, with its initiation date being October 12th 2018 and the most recent edit occurring on June 22nd 2022."
Answered by AI
How many participants are eligible to join this experiment?
"Affirmative. As per the clinicaltrials.gov record, this medical experiment is actively recruiting participants after initially being posted on October 12th 2018 and most recently edited on June 22nd 2022. A total of 60 patients are needed to be recruited from one location."
Answered by AI
What eligibility criteria must be met to join this experiment?
"To be eligible for this medical research, individuals should have a BMI indicating overweight and must fall within the demographic of 18 to 65 years old. Around 60 patients are required for successful trial completion."
Answered by AI
Is the eligibility age limit for this study above 35?
"This medical trial can accept participants aged between 18 and 65. There are also 239 studies available for those under the age of majority, as well as 763 trials catered to individuals above the pensionable age."
Answered by AI
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