Investigating how exercise affects insulin resistance and heart function in diabetes
Role of Microvascular Insulin Resistance and Cardiorespiratory Fitness Diabetes
This study is testing if regular exercise can help people with type 2 diabetes improve their heart function and reduce insulin resistance.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 30 Years to 55 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Trial ID | NCT04791371 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the impact of decreased insulin-mediated muscle perfusion on cardiac and skeletal muscle dysfunction in individuals with type 2 diabetes. It will assess whether cardiovascular exercise training can reduce insulin resistance and improve blood flow to the heart and muscles, potentially enhancing cardiac function and exercise performance. The research will involve participants who are sedentary and have a BMI between 25 and 40, including both men and women with and without type 2 diabetes. The study will take place at two sites: the University of Colorado and the University of Virginia.
Who should consider this trial
Good fit: Ideal candidates for this study are sedentary individuals with a BMI between 25 and 40, including those with and without type 2 diabetes.
Not a fit: Patients with documented cardiovascular disease, uncontrolled hypertension, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved exercise capacity and heart function in patients with type 2 diabetes, enhancing their overall quality of life.
How similar studies have performed: Other studies have shown promising results in improving insulin resistance and exercise capacity through similar exercise interventions, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Aurora, Colorado and 1 other locations
- University of Colorado — Aurora, Colorado, United States (Recruiting)
- University of Virginia — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Benjamin Juckett, MS
- Email: benjamin.juckett@cuanschutz.edu
- Phone: 303-724-1338
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.