- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04442451
Mechanisms of Fatigability With Diabetes
Mechanisms of Fatigability and the Protective Effects of Exercise in People With Diabetes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of the clinical trial is to determine the effectiveness of dynamic resistance exercise training coupled with blood flow restriction to improve fatigability and vascular function in people with Pre-D and T2D. People with Pre-D and T2D from Aim 1 will perform 8 weeks of dynamic unilateral resistance exercise training in which one leg is exercised with freely perfused conditions and the other leg with blood flow restriction.
We will assess fatigability, skeletal muscle metabolism, capillary density, and vascular function in people with Pre-D and T2D before and after a novel training intervention that couples dynamic resistance training with blood flow restriction to the exercising limb. This novel intervention has been shown to improve vascular function in young and older adults but has not been investigated in people with Pre-D and T2D. Endothelial function in intact large conduit arteries and arterioles isolated from skeletal muscle biopsies will be measured before and after the training intervention to assess whether the novel training improves vascular function along multiple levels of the vascular tree in people with Pre-D and T2D. Skeletal muscle blood flow through the femoral artery will be quantified with Doppler ultrasonography and skeletal muscle oxygenation will be measured with near infrared spectroscopy (NIRS) during a dynamic fatiguing knee extension exercise. We will closely match participant groups for physical activity levels, age, sex, and body mass index (BMI), because these confounders are not typically controlled for in other human studies.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sandra K Hunter, PhD
- Phone Number: 414-288-6673
- Email: sandra.hunter@marquette.edu
Study Contact Backup
- Name: Mirae Mastrolonardo, BSc
- Email: mirae.mastrolonardo@marquette.edu
Study Locations
-
-
Wisconsin
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Milwaukee, Wisconsin, United States, 53201
- Marquette University
-
Contact:
- Sandra K Hunter, PhD
- Phone Number: 414-288-6673
- Email: sandra.hunter@marquette.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control Exercise
Low-load knee extension resistance training (20% of 1-RM) without blood flow restriction.
A 10-cm wide inflatable cuff will be placed around the upper portion of the thigh but not inflated.
|
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.
|
Experimental: Blood Flow Restriction Exercise
Low-load knee extension resistance training (20% of 1-RM) with blood flow restriction using a 10-cm wide inflatable cuff placed around the most proximal part of the exercising thigh.
Blood flow will be restricted in the BFR leg at above the limb occlusion pressure of the and this will be determined prior to the exercise while the participant is seated in the knee extensor machine.
The cuff pressure during the BFR protocol will be 10 mmHg above limb occlusion pressure.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fatigability - Reduction in Power
Time Frame: One session before and then after 8 weeks of training
|
Reduction in limb power and maximal force in response to a dynamic fatiguing contraction.
|
One session before and then after 8 weeks of training
|
Strength - 1 Repetition Maximum
Time Frame: One session before and then after 8 weeks of training
|
Reduction in limb power and maximal force in response to a dynamic fatiguing contraction
|
One session before and then after 8 weeks of training
|
Strength - Maximal Voluntary Contraction (MVC)
Time Frame: 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.
|
One session before and then after 8 weeks of training
|
Leg Blood Flow
Time Frame: One 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.
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One session before and then after 8 weeks of training
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Skeletal Muscle Oxygenation
Time Frame: One 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.
|
One session before and then after 8 weeks of training
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Vasodilation in Skeletal Muscle Arterioles
Time Frame: One session before and then after 8 weeks of training
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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
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One session before and then after 8 weeks of training
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Muscle Metabolism - Phosphorus Nuclear Magnetic Resonance Spectroscopy (31P-MRS))
Time Frame: 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.
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One session before and then after 8 weeks of training
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Capillary density
Time Frame: One 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.
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One session before and after 8 weeks of training
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HR-2402
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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