Mechanisms of Fatigability With Diabetes

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-85
SponsorUniversity of Michigan

About this trial

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.

Eligibility criteria

Qualifiers

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%]

Disqualifiers

Signs or symptoms of neuropathy

Medications associated with advanced stages of T2D including insulin

Poor glycemic control (HbA1c>10%)

Peripheral edema

Trial design

Treatments tested in this trial

  • Control Exercise
  • Blood Flow Restriction Exercise

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Michigan

Lead sponsor

University of Illinois at Chicago

Collaborator

Medical College of Wisconsin

Collaborator

University of Wisconsin, Madison

Collaborator

National Institute on Aging (NIA)

Collaborator

Marquette University

Collaborator