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Study on Fatigability and Exercise in Pre-diabetes and Type 2 Diabetes

This study is looking at how exercise affects tiredness (fatigability) in people with pre-diabetes and type 2 diabetes. Researchers want to see if a special type of exercise, called Blood Flow Restriction Exercise, can improve how tired your leg muscles get and how well your blood vessels work. You would participate in 8 weeks of exercise, three times a week. The study will compare this special exercise to regular low-weight exercise. To join, you need to be between 30 and 85 years old and have pre-diabetes or type 2 diabetes. The study aims to see if these exercises reduce how tired your muscles get and improve your strength after 8 weeks. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 80 participants. It compares two types of exercise: Control Exercise and Blood Flow Restriction Exercise.
What's involved
You would attend 3 exercise sessions per week for 8 weeks. Measurements of fatigability and strength will be taken before and after the 8 weeks of training.
Compensation
Not stated in the trial record.
Follow-up
Measurements are taken one session before and then after 8 weeks of training.

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NCT04442451

Mechanisms of Fatigability With Diabetes

Recruiting
NAAges 30–85InterventionalBasic science
University of Michigan
~80 participants
Updated 2025-10-08 on ClinicalTrials.gov
What's tested:Control ExerciseBlood Flow Restriction Exercise

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fatigability - Reduction in Power
Measured over One session before and then after 8 weeks of training
+7 more outcomes measured

Conditions

Pre-diabetes
Type 2 Diabetes

Explore related trials

PrediabetesType 2 Diabetes Mellitus

Where it's being run

1 sites across 1 states
Michigan1

Who to contact

Sandra Hunter, PhD
[email protected]
(734) 647-9819
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Fatigability - Reduction in PowerOne session before and then after 8 weeks of training

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

  • Strength - 1 Repetition MaximumOne session before and then after 8 weeks of training

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

  • Strength - Maximal Voluntary Contraction (MVC)One session before and then after 8 weeks of training

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

  • Leg Blood FlowOne session before and then after 8 weeks of training

    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.

  • Skeletal Muscle OxygenationOne session before and then after 8 weeks of training

    Near-Infrared Spectroscopy recordings will be used to quantify blood flow kinetics of the knee extensor muscle tissue (rectus femoris and vastus lateralis) during the dynamic, fatiguing exercise in each leg.

  • Vasodilation in Skeletal Muscle ArteriolesOne session before and then after 8 weeks of training

    Vessel diameters of arterioles that are extracted and isolated from Skeletal muscle biopsies of the vastus lateralis will be measured in response to vasodilators and constrictors

  • Muscle Metabolism - Phosphorus Nuclear Magnetic Resonance Spectroscopy (31P-MRS))One session before and then after 8 weeks of training

    31P-MRS is used to noninvasively measure muscle metabolism by calculating intracellular ATP, ADP, phosphocreatine (PCr), inorganic phosphate (Pi), and pH in the quadriceps of participants. This measurement is conducted while participants perform fatiguing knee extensor exercise in the magnetic bore.

  • Capillary densityOne session before and after 8 weeks of training

    Immunohistochemical analysis will be performed on muscle biopsy samples to determine the number and density of capillaries for each fiber type.