What this study is
Pre-diabetes (Pre-D) is a precursor to type 2 diabetes (T2D) and characterized by increased exercise fatigability of lower limb muscles, that can impede exercise performance. The cause for the increased fatigability in people with Pre-D is not known. Given the profound vascular disease present in people who have had uncontrolled diabetes for several years, we will determine whether dynamic, fatiguing contractions of the lower limb muscles in people with Pre-D are limited by vascular dysfunction at multiple levels along the vascular tree including the artery, arteriole, and/or capillary. This clinical trial involves a novel exercise training regime involving blood flow restriction to the exercising limb will be used as a probe to further understand the vascular mechanisms for increased fatigability in people with Pre-D and T2D. The long-term goal is to better understand what limits exercise and functional performance in people with diabetes to help develop targeted, more effective exercise programs.
What's being tested
- Control Exercise
Intervention · OTHER
Each participant will attend 3 sessions per week for 8 weeks. Participants will perform low-load knee extension resistance training (20% of 1-RM) without blood flow restriction on the designated leg for 4 sets of contractions with 15 contractions per set of contractions with a 30 second rest between each set of contractions.
- Blood Flow Restriction Exercise
Intervention · OTHER
Each participant will attend 3 sessions per week for 8 weeks. Participants will perform low-load knee extension resistance training (20% of 1-RM) with blood flow restriction on the designated leg for 4 sets of contractions with 15 contractions per set of contractions with a 30 second rest between each set of contractions.
Study details
- Official title
- Mechanisms of Fatigability and the Protective Effects of Exercise in People With Diabetes
- Sponsor
- University of Michigan
- Conditions
- Pre-diabetes · Type 2 Diabetes
- Enrolling
- 80 people
- Starts
- 2022-09-01
- Est. completion
- 2027-08-31
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 30 Years – 85 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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%]
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Michigan
Ann Arbor, Michigan, United States
- Sandra Hunter, PhD · Contact(734) 647-9819sandrahu@umich.edu
- Sarah Lessila, MS · Contact(734) 647-6019slessila@umich.edu
Recruiting
Study team
Sponsor
University of Michigan
Study ID HUM00255375
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.