Mechanisms of Fatigability and the Protective Effects of Exercise in People With Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 85
Healthy Volunteers: f
View:

• 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 \[elevated glycosylated hemoglobin (HbA1c) \>6.5% and \<10%\]

Locations
United States
Michigan
University of Michigan
RECRUITING
Ann Arbor
Contact Information
Primary
Sandra Hunter, PhD
sandrahu@umich.edu
(734) 647-9819
Backup
Sarah Lessila, MSc
slessila@umich.edu
Time Frame
Start Date: 2022-09-01
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 80
Treatments
Experimental: Control Exercise
Low-load knee extension resistance training (20% of 1-RM) without blood flow restriction. A 10-cm wide inflatable cuff will be placed around the upper portion of the thigh but not inflated.
Experimental: Blood Flow Restriction Exercise
Low-load knee extension resistance training (20% of 1-RM) with blood flow restriction using a 10-cm wide inflatable cuff placed around the most proximal part of the exercising thigh. Blood flow will be restricted in the BFR leg at above the limb occlusion pressure of the and this will be determined prior to the exercise while the participant is seated in the knee extensor machine. The cuff pressure during the BFR protocol will be 10 mmHg above limb occlusion pressure.
Related Therapeutic Areas
Sponsors
Collaborators: Marquette University, Medical College of Wisconsin, University of Wisconsin, Madison, National Institute on Aging (NIA), University of Illinois at Chicago
Leads: University of Michigan

This content was sourced from clinicaltrials.gov