12 Participants Needed

Exercise for Insulin Resistance in Type 2 Diabetes

(EXPET Trial)

RD
Overseen ByRecruitment Department
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Translational Research Institute for Metabolism and Diabetes, Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you are not currently taking insulin, injectable incretin mimetics, thiazolidinediones, or more than two glucose-lowering medications. You also cannot be on certain medications like blood thinners, anti-inflammatory drugs, or beta-blockers. If you are on these medications, you may need to stop them to participate.

What data supports the effectiveness of the treatment Exercise for Insulin Resistance in Type 2 Diabetes?

Research shows that insulin resistance is linked to the amount of fat stored in muscles and around the abdomen. Improving muscle function and reducing fat content through exercise can enhance insulin sensitivity, which is how well the body responds to insulin.12345

Is the exercise treatment for insulin resistance in type 2 diabetes safe?

The procedures involved in the study, such as adipose tissue biopsy and muscle biopsy, are generally safe. Adipose tissue biopsy using a mini-liposuction technique is safe with minimal restrictions on activities post-procedure. Muscle biopsy has a low incidence of minor side effects like pain and bruising, with no significant difference in safety between healthy and chronically ill individuals.56789

How does the treatment of adipose and muscle biopsy differ from other treatments for insulin resistance in type 2 diabetes?

Adipose and muscle biopsies are unique because they are not treatments themselves but diagnostic procedures that help researchers understand how exercise affects insulin resistance in type 2 diabetes. Unlike medications or lifestyle changes, these biopsies provide direct insights into the cellular and metabolic changes in muscle and fat tissue, which can guide more personalized treatment strategies.1011121314

What is the purpose of this trial?

The overall aim of this pilot study is to investigate the effects of exercise training on skeletal muscle and adipose tissue insulin resistance in subjects with Type 2 Diabetes (T2D).

Research Team

BG

Bret Goodpaster, PhD

Principal Investigator

Scientific Director | Senior Investigator

Eligibility Criteria

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.

Inclusion Criteria

I am between 30 and 65 years old.
Sedentary (1 day or less per week of structured exercise)
I have type 2 diabetes.
See 4 more

Exclusion Criteria

Resting blood pressure ≥ 160/100 mm Hg
Triglycerides ≥ 500 mg/dL
Pregnancy during the previous 6 months, lactating, or planned pregnancy in the next year
See 25 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exercise Intervention

Participants undergo exercise training to assess effects on skeletal muscle and adipose tissue insulin resistance

Duration not specified

Assessment

Muscle glucose uptake is assessed pre and post exercise intervention using PET imaging and hyperinsulinemic euglycemic clamp

24 hours

Follow-up

Participants are monitored for safety and effectiveness after the exercise intervention

4 weeks

Treatment Details

Interventions

  • Adipose Tissue Biopsy
  • Exercise Testing (VO2max)
  • Hyperinsulinemic euglycemic clamp
  • Maximal ATP Production (ATPmax)
  • Muscle Biopsy
  • PET imaging
Trial Overview 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: All ParticipantsExperimental Treatment6 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Translational Research Institute for Metabolism and Diabetes, Florida

Lead Sponsor

Trials
41
Recruited
3,600+

AdventHealth Translational Research Institute

Lead Sponsor

Trials
51
Recruited
5,900+

Findings from Research

In a study of 75 middle-aged and older adults with overweight or obesity, higher levels of intermuscular adipose tissue (IMAT) were linked to increased fasting glucose levels and insulin resistance, suggesting a potential risk factor for metabolic issues.
The saturation of intramyocellular lipids (IMCL) was also positively associated with fasting glucose concentration, indicating that both IMAT and IMCL saturation may contribute to insulin resistance in this population.
Intermuscular Adipose Tissue Content and Intramyocellular Lipid Fatty Acid Saturation Are Associated with Glucose Homeostasis in Middle-Aged and Older Adults.Kim, JE., Dunville, K., Li, J., et al.[2022]
In a study of 66 patients who underwent repeat muscle biopsies, 24% received a definitive diagnosis that changed their management, highlighting the potential importance of this procedure in diagnosing myopathy.
Additionally, 45% of repeat biopsies provided clinically useful information, such as ruling out other conditions or confirming previous diagnoses, which can guide treatment decisions.
Role of repeat skeletal muscle biopsy: how useful is it?Goutman, SA., Prayson, RA.[2018]
In a study of 461 older men, higher levels of circulating adiponectin were associated with increased capillary density and a higher proportion of type I muscle fibers, which are linked to better insulin sensitivity.
Adiponectin appears to partially mediate the relationship between muscle morphology and insulin sensitivity, suggesting that improving muscle structure could enhance metabolic health.
Associations of serum adiponectin with skeletal muscle morphology and insulin sensitivity.Ingelsson, E., Arnlöv, J., Zethelius, B., et al.[2012]

References

Intermuscular Adipose Tissue Content and Intramyocellular Lipid Fatty Acid Saturation Are Associated with Glucose Homeostasis in Middle-Aged and Older Adults. [2022]
Role of repeat skeletal muscle biopsy: how useful is it? [2018]
Associations of serum adiponectin with skeletal muscle morphology and insulin sensitivity. [2012]
Independent influences of central fat and skeletal muscle lipids on insulin sensitivity. [2011]
Adipose tissue content, muscle performance and physical function in obese adults with type 2 diabetes mellitus and peripheral neuropathy. [2022]
Human Subcutaneous Adipose Tissue Sampling using a Mini-liposuction Technique. [2021]
Percutaneous adipose tissue biopsy by mini-liposuction for metabolic studies. [2017]
Incidence of adverse events associated with percutaneous muscular biopsy among healthy and diseased subjects. [2012]
How to Measure Adipose Tissue Insulin Sensitivity. [2022]
Exercise and insulin resistance in type 2 diabetes mellitus: A systematic review and meta-analysis. [2019]
Adaptations to exercise training within skeletal muscle in adults with type 2 diabetes or impaired glucose tolerance: a systematic review. [2018]
Insulin resistance and associated metabolic abnormalities in muscle: effects of exercise. [2019]
Resistance exercise did not alter intramuscular adipose tissue but reduced retinol-binding protein-4 concentration in individuals with type 2 diabetes mellitus. [2022]
14.United Statespubmed.ncbi.nlm.nih.gov
Intramyocellular triglyceride content is a determinant of in vivo insulin resistance in humans: a 1H-13C nuclear magnetic resonance spectroscopy assessment in offspring of type 2 diabetic parents. [2022]
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