Mechanisms of Fatigability With Diabetes

Recruiting now · Not applicable

Conditions studied: Pre-diabetes, Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT04442451

Run by

University of Michigan

People needed

80

Starts

2022-09-01

Expected to finish

2027-08-31

Last updated by the study team

2025-10-08

Who can join

Age: 30 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You 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 may not qualify 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

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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