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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

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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Individual steps of muscle glucose uptake (post-exercise)

Individual steps of muscle glucose uptake (pre-exercise)

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

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Translational Research Institute for Metabolism and Diabetes, FloridaLead Sponsor

40 Previous Clinical Trials

3,609 Total Patients Enrolled

AdventHealth Translational Research InstituteLead Sponsor

48 Previous Clinical Trials

5,616 Total Patients Enrolled

Bret Goodpaster, PhDPrincipal InvestigatorScientific Director | Senior Investigator

5 Previous Clinical Trials

492 Total Patients Enrolled

~0 spots leftby Aug 2024

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