RECRUITING

Mechanisms of Fatigability With Diabetes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-09-01
Study Completion:2027-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04442451

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women adults 30 years to 85 years or less
  2. * Pre-diabetes \[glycosylated hemoglobin (HbA1c) of 5.7-6.4% and fasting plasma glucose 100-125 mg/dL at the time of initial screening\]
  3. * Controls \[normoglycemic with a HbA1c level ≤5.6% and fasting blood glucose ≤ 99 mg/dL (5.5 mmol/L)\]
  4. * Type 2 Diabetes Mellitus \[elevated glycosylated hemoglobin (HbA1c) \>6.5% and \<10%\]
  1. * Signs or symptoms of neuropathy
  2. * Medications associated with advanced stages of T2D including insulin
  3. * Poor glycemic control (HbA1c\>10%)
  4. * Peripheral edema
  5. * Severe obesity (BMI, \>45kg·m-2)
  6. * Untreated hypothyroidism
  7. * Smoking
  8. * Hypertension
  9. * Cardiovascular or musculoskeletal disease that preclude exercise testing
  10. * Hormone replacement drugs or vasoactive medications

Contacts and Locations

Study Contact

Christopher Sundberg, PhD
CONTACT
(414) 288-5607
christopher.sundberg@marquette.edu
Sarah Lessila, MSc
CONTACT
slessila@umich.edu

Study Locations (Sites)

Marquette University
Milwaukee, Wisconsin, 53201
United States

Collaborators and Investigators

Sponsor: Marquette University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-01
Study Completion Date2027-04-01

Study Record Updates

Study Start Date2022-09-01
Study Completion Date2027-04-01

Terms related to this study

Keywords Provided by Researchers

  • Diabetes
  • Pre-diabetes
  • Fatigability
  • Blood Flow Restriction Training
  • Vascular Function
  • Muscle Fatigue

Additional Relevant MeSH Terms

  • Pre-diabetes
  • Type 2 Diabetes