Mechanisms of Fatigability With Diabetes

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-85
SponsorUniversity of Michigan

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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%]

Disqualifiers

Signs or symptoms of neuropathy

Medications associated with advanced stages of T2D including insulin

Poor glycemic control (HbA1c>10%)

Peripheral edema

Trial design

Design model

Parallel

Treatments tested in this trial

  • Control Exercise

    Other intervention

    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.

  • Blood Flow Restriction Exercise

    Other intervention

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Control ExerciseExperimental treatment 1 intervention
Group B: Blood Flow Restriction ExerciseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Fatigability - Reduction in Power

Reduction in limb power and maximal force in response to a dynamic fatiguing contraction.

Time frame
One session before and then after 8 weeks of training
2

Strength - 1 Repetition Maximum

Reduction in limb power and maximal force in response to a dynamic fatiguing contraction

Time frame
One session before and then after 8 weeks of training
3

Strength - Maximal Voluntary Contraction (MVC)

Changes in MVC after 8 weeks resistance training. MVC is the greatest force generated during a brief isometric contraction.

Time frame
One session before and then after 8 weeks of training
4

Leg Blood Flow

Femoral artery mean blood velocity and femoral artery diameter will be measured using Doppler ultrasonography before and immediately after the fatiguing task in each leg.

Time frame
One session before and then after 8 weeks of training

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan

Lead sponsor

University of Illinois at Chicago

Collaborator

Medical College of Wisconsin

Collaborator

University of Wisconsin, Madison

Collaborator

National Institute on Aging (NIA)

Collaborator

Marquette University

Collaborator