Actively Recruiting

Phase Not Applicable
Age: 30Years - 85Years
All Genders
NCT04442451

Mechanisms of Fatigability With Diabetes

Led by University of Michigan · Updated on 2025-10-08

80

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

Sponsors

U

University of Michigan

Lead Sponsor

U

University of Illinois at Chicago

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Mechanisms of Fatigability With Diabetes

Who Can Participate

Age: 30Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 30 to 85 years
  • Diagnosed with pre-diabetes (HbA1c 5.7-6.4% and fasting glucose 100-125 mg/dL)
  • Controls with normal blood sugar levels (HbA1c 645.6% and fasting glucose 6499 mg/dL)
  • Diagnosed with type 2 diabetes mellitus (HbA1c >6.5% and <10%)
Not Eligible

You will not qualify if you...

  • Signs or symptoms of neuropathy
  • Use of medications associated with advanced stages of type 2 diabetes, including insulin
  • Poor blood sugar control (HbA1c >10%)
  • Peripheral edema
  • Severe obesity (BMI >45 kg/m2)
  • Untreated hypothyroidism
  • Current smoking
  • Hypertension
  • Cardiovascular or musculoskeletal disease preventing exercise testing
  • Use of hormone replacement drugs or vasoactive medications

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Trial Site Locations

Total: 1 location

1

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

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Research Team

S

Sandra Hunter, PhD

CONTACT

S

Sarah Lessila, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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