NCT04442451 Mechanisms of Fatigability With Diabetes
| NCT ID | NCT04442451 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan |
| Condition | Pre-diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2022-09-01 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 \[elevated glycosylated hemoglobin (HbA1c) \>6.5% and \<10%\] Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04442451 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 85 Years, studying Pre-diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04442451 currently recruiting?
Yes, NCT04442451 is actively recruiting participants. Contact the research team at sandrahu@umich.edu for enrollment information.
Where is the NCT04442451 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT04442451 clinical trial?
NCT04442451 is sponsored by University of Michigan. The trial plans to enroll 80 participants.
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