Role of Microvascular Insulin Resistance and Cardiorespiratory Fitness Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cardiovascular exercise.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes, Overweight and Obesity. Basic parameters: 30 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The goal of this two-site grant proposal is to determine the role of the decreased insulin-mediated muscle perfusion found in type 2 diabetes in contributing to the development of cardiac and skeletal muscle dysfunction and subsequent functional exercise impairment. In addition, it is also our goal to determine whether exercise training attenuates insulin resistance and restores insulin-mediated perfusion to the heart and to skeletal muscle, leading to improved cardiac function and exercise performance.
Detailed description
It is our goal to determine whether exercise training attenuates insulin resistance and restores insulin-mediated perfusion to the heart and to skeletal muscle, leading to improved cardiac function and exercise performance. Data from our two research teams suggest that the cardiac and skeletal muscle microvascular dysfunction present in people with type 2 diabetes contributes to limitations in cardiac and skeletal muscle function associated with impaired functional exercise capacity (a major predictor of CV and all-cause mortality). Insulin action is a potent predictor of the functional exercise capacity impairment in type 2 diabetes. The exact relationship between insulin action, cardiac and muscle dysfunction, cardiac and skeletal muscle perfusion and decreased functional exercise capacity in type 2 diabetes remains unclear.
Interventions
- Behavioral Cardiovascular exercise
15 weeks of cardiovascular exercise 3x/week for 50 minutes/session
Primary outcome measures
- Change in peak oxygen consumption (VO2) [Time frame: Through study completion, approximately 4 months]
- Change in insulin sensitivity [Time frame: Through study completion, approximately 4 months]
Eligibility criteria
Inclusion criteria
- Sedentary (defined as less than 1 hour per week of physical activity)
- BMI: 25-40
- Men and women with and without type 2 diabetes
Exclusion criteria
- Documented cardiovascular disease
- Uncontrolled hypertension: disease systolic blood pressure (SBP) > 150, diastolic blood pressure (DBP)> 110
- Obstructive pulmonary disease or asthma
- Peripheral neuropathy
- Physical impairment that would limit exercise ability
- Subjects taking beta blockers, calcium channel blockers, insulin, or Thiazolidinediones (TZD)
- Current or past smoking within the last 1 years
- Current tobacco use
- Anemia
- Control HbA1c > 5.7, T2DM HbA1c > 9
- Pregnant, nursing or hormonal therapy (other than contraceptives)
- Peri or post-menopausal women
- Type 1 diabetes
- Hepatic or renal disease.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- University of Colorado — Aurora
- University of Virginia — Charlottesville
Publications
- Park S, Englund EK, Fujiwara T, Enge D, Schafer M, Gerstner Saucedo J, Clark EW, Abushamat LA, Scalzo RL, Fonseca B, Hunter KS, Sammel MD, Regensteiner JG, Reusch JEB, Barker AJ. Comprehensive CMR evaluation including 4D flow-derived E/A vorticity ratio in overweight adults with and without type 2 diabetes mellitus. Cardiovasc Diabetol. 2025 Dec 8;25(1):7. doi: 10.1186/s12933-025-02999-9. PMID 41361416
Identifiers
NCT: NCT04791371 · 20-2723 · R01DK124344