Actively Recruiting
Mechanisms of Fatigability and the Protective Effects of Exercise in People With Diabetes
Led by University of Michigan · Updated on 2025-10-08
80
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
U
University of Michigan
Lead Sponsor
U
University of Illinois at Chicago
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the causes of increased muscle fatigue during exercise in people with pre-diabetes (Pre-D) and type 2 diabetes (T2D). The study aims to understand whether blood vessel problems at various levels contribute to this fatigue. This trial evaluates a new exercise training method that uses blood flow restriction to better understand how vascular function affects exercise performance in these groups. Participants with Pre-D and T2D will engage in an 8-week exercise program involving dynamic resistance training of the leg muscles. One leg will exercise normally without blood flow restriction, while the other leg will exercise with blood flow restricted by an inflatable cuff. This approach tests how restricting blood flow during exercise influences muscle fatigue and vascular health. During the study, participants will attend three exercise sessions per week for eight weeks. Researchers will measure muscle fatigue, strength, blood flow, oxygen levels in muscles, and blood vessel function before and after the training. Various assessments include muscle biopsies, Doppler ultrasound, and near infrared spectroscopy (NIRS). The study monitors changes in muscle metabolism, capillary density, and vascular responses to evaluate effects of the training program.
CONDITIONS
Brief Title
Mechanisms of Fatigability With Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 30 to 85 years
- Diagnosed with pre-diabetes (HbA1c 5.7-6.4% and fasting glucose 100-125 mg/dL) or type 2 diabetes (HbA1c above 6.5% and below 10%)
- Control participants with normal blood sugar levels (HbA1c ≤5.6% and fasting glucose ≤99 mg/dL)
- Men and women
You will not qualify if you...
- Signs or symptoms of neuropathy
- Use of insulin or medications linked to advanced type 2 diabetes
- Poor blood sugar control (HbA1c over 10%)
- Peripheral swelling (edema)
- Severe obesity (BMI over 45 kg/m²)
- Untreated hypothyroidism
- Smoking
- High blood pressure (hypertension)
- Cardiovascular or musculoskeletal diseases preventing exercise testing
- Use of hormone replacement drugs or vasoactive medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants perform 8 weeks of low-load knee extension resistance training three times per week, with one leg exercising under blood flow restriction and the other leg exercising without restriction.
3 sessions per week
Duration - Up to 1 week after treatment
Participants undergo assessments to measure fatigability, strength, leg blood flow, skeletal muscle oxygenation, vasodilation, muscle metabolism, and capillary density before and after the training intervention.
2 assessment visits (before and after training)
Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
S
Sandra Hunter, PhD
S
Sarah Lessila, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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