Recruiting

Mechanisms of Fatigability With Diabetes

ClinicalTrials.gov IDNCT04442451

PhaseNA

Enrollment80

SponsorUniversity of Michigan

Age30 Years

SexALL

I'm interested View official listing

Conditions studied

Pre-diabetes, Type 2 Diabetes

About this study

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.

Interventions

Other: Control Exercise — Each participant will attend 3 sessions per week for 8 weeks. Participants will perform low-load knee extension resistance training (20% of 1-RM) without blood flow restriction on the designated leg for 4 sets of contractions with 15 contractions per set of contractions with a 30 second rest between each set of contractions.
Other: Blood Flow Restriction Exercise — Each participant will attend 3 sessions per week for 8 weeks. Participants will perform low-load knee extension resistance training (20% of 1-RM) with blood flow restriction on the designated leg for 4 sets of contractions with 15 contractions per set of contractions with a 30 second rest between each set of contractions.

Primary outcomes

Fatigability - Reduction in Power (One session before and then after 8 weeks of training)
Strength - 1 Repetition Maximum (One session before and then after 8 weeks of training)
Strength - Maximal Voluntary Contraction (MVC) (One session before and then after 8 weeks of training)
Leg Blood Flow (One session before and then after 8 weeks of training)

Eligibility information

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

Study locations

University of Michigan, Ann Arbor, Michigan 48109 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-03.