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Exercise for Insulin Resistance in Type 2 Diabetes (EXPET Trial)

N/A
Recruiting
Led By Bret Goodpaster, PhD
Research Sponsored by Translational Research Institute for Metabolism and Diabetes, Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 30-65 years
Type 2 diabetes mellitus determined by self-report or by a fasting glucose >126mg/dl
Must not have
Major surgery on the abdomen, pelvis, or lower extremities within previous 3 months
Taking more than two glucose-lowering medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at how exercise affects insulin resistance in people with Type 2 Diabetes.

Who is the study for?
This trial is for adults aged 30-65 with Type 2 Diabetes who are sedentary, have a BMI of 25-45 kg/m2, and haven't had significant weight changes recently. They must not be on more than two glucose-lowering medications or insulin and should be free from major diseases or conditions that could interfere with the study.
What is being tested?
The study tests how exercise affects insulin resistance in people with Type 2 Diabetes by using PET imaging, muscle and fat biopsies, and measuring maximum ATP production. Participants will undergo an exercise regimen to see if it improves their condition.
What are the potential side effects?
Potential side effects may include discomfort at biopsy sites, reactions to the contrast agent used in PET imaging (like mild itching or rash), risks associated with exercising such as muscle strain, and possible bruising from the clamp procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 30 and 65 years old.
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I have type 2 diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had major surgery on my abdomen, pelvis, or legs in the last 3 months.
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I am taking more than two medications to lower my blood sugar.
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I am currently taking insulin or diabetes injections.
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I do not have any severe chronic diseases like heart, kidney, liver, or lung conditions.
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I have an active cancer, not just basal cell carcinoma.
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I am on blood thinners or anti-platelet medications that can't be stopped for tests.
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I cannot perform the required exercises for the study.
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I cannot undergo MRI scans due to physical size restrictions.
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I am not taking medications that affect my energy or weight.
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I am currently taking beta-blockers.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Individual steps of muscle glucose uptake (post-exercise)
Individual steps of muscle glucose uptake (pre-exercise)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: All ParticipantsExperimental Treatment6 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Adipose Tissue Biopsy
2015
N/A
~120
Muscle Biopsy
2016
Completed Phase 1
~150

Find a Location

Who is running the clinical trial?

Translational Research Institute for Metabolism and Diabetes, FloridaLead Sponsor
40 Previous Clinical Trials
3,652 Total Patients Enrolled
AdventHealth Translational Research InstituteLead Sponsor
50 Previous Clinical Trials
5,952 Total Patients Enrolled
Bret Goodpaster, PhDPrincipal InvestigatorScientific Director | Senior Investigator
5 Previous Clinical Trials
502 Total Patients Enrolled
~1 spots leftby Jun 2025
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