Type 2 Diabetes Clinical Trial
Official title:
Mechanisms of Fatigability and the Protective Effects of Exercise in People With Diabetes
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Marquette University | Milwaukee | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Marquette University | Medical College of Wisconsin, University of Illinois at Chicago |
United States,
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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