NCT04442451Recruiting
Mechanisms of Fatigability With Diabetes
Mechanisms of Fatigability and the Protective Effects of Exercise in People With Diabetes
Source: ClinicalTrials.gov · Last updated 1 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 18 Jun 2020
- Start date
- 1 Sept 2022
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- University of Michigan
- Diseases
- Type 2 diabetes
- NCT number
- NCT04442451
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 1 Sept 2022 to the primary completion date, 1 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Medications associated with advanced stages of T2D including insulin
- Hormone replacement drugs or vasoactive medications
Other illness
- Hypertension
- Cardiovascular or musculoskeletal disease that preclude exercise testing
Lab values
- Poor glycemic control (HbA1c\>10%)
Other
- Signs or symptoms of neuropathy
- Peripheral edema
- Severe obesity (BMI, \>45kg·m-2)
- Untreated hypothyroidism
- Smoking
Who the study is looking for
- 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 \[elevated glycosylated hemoglobin (HbA1c) \>6.5% and \<10%\]
Age in the registry: 30 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.