Understanding Fatigability in People with Diabetes
Mechanisms of Fatigability and the Protective Effects of Exercise in People With Diabetes
This study is testing how different exercise methods can help people with pre-diabetes and type 2 diabetes feel less tired during workouts and improve their overall muscle health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 30 Years to 85 Years |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT04442451 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the mechanisms behind increased exercise fatigability in individuals with pre-diabetes and type 2 diabetes. Participants will undergo an 8-week dynamic resistance exercise program, with one leg exercising under normal blood flow conditions and the other under blood flow restriction. The study aims to assess changes in fatigability, skeletal muscle metabolism, capillary density, and vascular function before and after the intervention. By exploring these factors, the research seeks to identify how vascular dysfunction contributes to exercise limitations in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 30 to 85 with pre-diabetes or type 2 diabetes.
Not a fit: Patients with severe obesity, uncontrolled diabetes, or significant cardiovascular or musculoskeletal diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved exercise interventions that enhance physical performance and quality of life for patients with diabetes.
How similar studies have performed: While similar interventions have shown promise in other populations, this specific approach has not been extensively tested in individuals with pre-diabetes and type 2 diabetes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women adults 30 years to 85 years or less * Pre-diabetes \[glycosylated hemoglobin (HbA1c) of 5.7-6.4% and fasting plasma glucose 100-125 mg/dL at the time of initial screening\] * Controls \[normoglycemic with a HbA1c level ≤5.6% and fasting blood glucose ≤ 99 mg/dL (5.5 mmol/L)\] * Type 2 Diabetes Mellitus \[elevated glycosylated hemoglobin (HbA1c) \>6.5% and \<10%\] Exclusion Criteria: * Signs or symptoms of neuropathy * Medications associated with advanced stages of T2D including insulin * Poor glycemic control (HbA1c\>10%) * Peripheral edema * Severe obesity (BMI, \>45kg·m-2) * Untreated hypothyroidism * Smoking * Hypertension * Cardiovascular or musculoskeletal disease that preclude exercise testing * Hormone replacement drugs or vasoactive medications
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Study coordinator: Sandra Hunter, PhD
- Email: sandrahu@umich.edu
- Phone: (734) 647-9819
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.