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Resistance Exercise for Insulin Resistance
N/A
Recruiting
Led By K Sreekumaran Nair
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
hip to waist ratio of >0.85 in women and 1.0 in men
hip to waist ratio of <0.76 in women and 0.90 in men
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and after 3 months
Awards & highlights
Study Summary
This trial will investigate how resistance exercise training can improve insulin resistance, muscle loss, and performance by studying two genes.
Who is the study for?
This trial is for people aged 50-75 with obesity (BMI 30-38) and insulin resistance, indicated by fasting glucose levels of ≥100-140 mg/dl. Participants should not be on certain medications like beta blockers or anti-hyperglycemic drugs, including metformin, and must not have a history of alcohol/drug abuse or significant medical conditions that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing how resistance exercise training can improve muscle mass, performance, and insulin sensitivity in those who are insulin resistant. It will explore if this type of exercise affects two specific genes believed to help muscles use glucose better and reduce oxidative stress.See study design
What are the potential side effects?
Resistance exercise generally has minimal side effects but may include muscle soreness, fatigue, or injury if not performed correctly. The risk increases for individuals with pre-existing health conditions; however, these risks will be managed under supervision in the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My hip to waist ratio is above 0.85 (if I am a woman) or 1.0 (if I am a man).
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My hip to waist ratio is below the required threshold.
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I am between 50 and 75 years old.
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My BMI is between 30 and 38.
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My hip to waist ratio is below the required threshold for my gender.
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I am between 50 and 75 years old.
Select...
My hip to waist ratio is above 0.85 (if I am a woman) or 1.0 (if I am a man).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and after 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and after 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in PGC1a Expression
Change in PPARb Expression
Change in Protein degradation
Secondary outcome measures
Change in Glycogen Content
Change in Glycogen Synthase
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Insulin Resistant Exercise GroupExperimental Treatment1 Intervention
Resistance (RE) training will be performed 4 days per week using a combination of upper and lower body exercises at 8-12 repetitions per set. Resistance training will be performed using a combination of upper and lower body exercises using machine and free weights. Upper body exercises are chest press, incline press, seated row, lat pull down, triceps extension, biceps curl and lateral raises. Major muscle groups for upper body exercises will include chest (pectoralis major and minor), arm (biceps and triceps), shoulder (deltoids) and back (latissimus dorsi and rhomboids). Lower body exercises are leg press, lunge (with body weight progressing to dumbbells), seated leg extension, seated leg curl, calf raises and abdominal crunches. Major muscle groups for the lower body exercises will be thighs (quadriceps and hamstrings), calves (gastrocnemius and soleus) and core (rectus abdominus and obliques).
Group II: Insulin Resistant Control GroupActive Control1 Intervention
Participants in this group will perform no exercise for the 3 month study period.
Group III: Insulin Sensitive Lean GroupActive Control1 Intervention
Participants in this group will have a baseline study for comparison to the insulin resistant groups.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Resistance Exercise
2017
Completed Phase 4
~880
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,210 Previous Clinical Trials
3,767,190 Total Patients Enrolled
20 Trials studying Insulin Resistance
762 Patients Enrolled for Insulin Resistance
National Institute on Aging (NIA)NIH
1,672 Previous Clinical Trials
28,018,599 Total Patients Enrolled
15 Trials studying Insulin Resistance
995 Patients Enrolled for Insulin Resistance
K Sreekumaran NairPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
45 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If you are in the Lean Group, your fasting glucose level must be less than 100 mg/dl.My doctor agrees all my medications are safe for this trial.My hip to waist ratio is below the required threshold for my gender.Your body mass index (BMI) is between 30 and 38.I am between 50 and 75 years old.I am not taking medications like beta blockers that affect mitochondrial biology.My hip to waist ratio is below the required threshold.I don't have any recent injuries, muscle disorders, or other serious health issues that could interfere with the study.Your blood pressure is too high and not under control.My kidney function is reduced.I am taking medication to manage my blood sugar levels, including metformin.My BMI is between 30 and 38.Your blood sugar level when you haven't eaten is between 100 and 140 milligrams per deciliter.You regularly drink too much alcohol or use illegal drugs for fun.I have heart disease or heart failure.I am taking oral steroids.I am between 50 and 75 years old.I have an ongoing infection that won't clear before the study starts.I have a diagnosed adrenal gland disorder.You exercise regularly at least two days a week.I have been diagnosed with gastroparesis.Your liver function test shows that certain enzymes are more than double the normal level.Your thyroid disease is not well controlled, with very low or very high TSH levels.I have not been hospitalized for psychiatric reasons in the last 6 months.My hip to waist ratio is above 0.85 (if I am a woman) or 1.0 (if I am a man).The researcher thinks that any current medication may not be safe for you to participate in the study.My hip to waist ratio is above 0.85 (if I am a woman) or 1.0 (if I am a man).
Research Study Groups:
This trial has the following groups:- Group 1: Insulin Resistant Exercise Group
- Group 2: Insulin Resistant Control Group
- Group 3: Insulin Sensitive Lean Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Insulin Resistance Patient Testimony for trial: Trial Name: NCT04158375 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment in this clinical experiment still available?
"According to medical archives hosted on clinicaltrials.gov, this research initiative is currently recruiting participants. This study was first made available for enrollment on September 2nd 2020 and has most recently been updated in April 11th 2022."
Answered by AI
How many participants are included in the scope of this research endeavor?
"Indeed, the clinical trial is currently seeking participants. Initially posted on September 2nd 2020 with its most recent alteration on April 11th 2022, this medical study requires 64 patients to be drawn from 3 distinct sites."
Answered by AI
Is the study open to participants aged 18 and over?
"This clinical trial has a set age range of 50 to 75 years old. For those under 18, there are 219 trials and for seniors over 65, 665 separate studies are available."
Answered by AI
Am I eligible to join the experiment?
"In order to qualify for the trial, individuals must be between 50 and 75 years old and have a BMI that classifies them as obese. 64 participants are needed in total."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Arizona
What site did they apply to?
Mayo Clinic in Arizona
Mayo Clinic in Florida
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
1
Why did patients apply to this trial?
I’m tiered of being overweight want to improve my health!!
PatientReceived 2+ prior treatments
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