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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04442451
Other study ID # HR-2402
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2024
Est. completion date April 1, 2027

Study information

Verified date August 2023
Source Marquette University
Contact Sandra K Hunter, PhD
Phone 414-288-6673
Email sandra.hunter@marquette.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date April 1, 2027
Est. primary completion date January 1, 2027
Accepts healthy volunteers No
Gender All
Age group 30 Years to 85 Years
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
United States Marquette University Milwaukee Wisconsin

Sponsors (3)

Lead Sponsor Collaborator
Marquette University Medical College of Wisconsin, University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fatigability - Reduction in Power Reduction in limb power and maximal force in response to a dynamic fatiguing contraction. One session before and then after 8 weeks of training
Primary Strength - 1 Repetition Maximum Reduction in limb power and maximal force in response to a dynamic fatiguing contraction One session before and then after 8 weeks of training
Primary Strength - Maximal Voluntary Contraction (MVC) 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
Primary 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. One session before and then after 8 weeks of training
Primary Skeletal Muscle Oxygenation 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
Primary Vasodilation in Skeletal Muscle Arterioles 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 One session before and then after 8 weeks of training
Primary Muscle Metabolism - Phosphorus Nuclear Magnetic Resonance Spectroscopy (31P-MRS)) 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. One session before and then after 8 weeks of training
Primary Capillary density Immunohistochemical analysis will be performed on muscle biopsy samples to determine the number and density of capillaries for each fiber type. One session before and after 8 weeks of training
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