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Role of Microvascular Insulin Resistance and Cardiorespiratory Fitness Diabetes

Role of Microvascular Insulin Resistance and Cardiorespiratory Fitness Diabetes

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04791371
Acronym
REACH
Enrollment
150
Registered
2021-03-10
Start date
2022-06-17
Completion date
2027-02-15
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity, Type 2 Diabetes

Brief summary

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

15 weeks of cardiovascular exercise 3x/week for 50 minutes/session

Sponsors

University of Colorado, Denver
Lead SponsorOTHER
University of Virginia
CollaboratorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 55 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in peak oxygen consumption (VO2)Through study completion, approximately 4 monthsSubjects' peak oxygen consumption will be tested on a stationary bike before and after 15 weeks of exercise
Change in insulin sensitivityThrough study completion, approximately 4 monthsThe investigators will evaluate the changes in insulin sensitivity utilizing a euglycemic insulin clamp

Countries

United States

Contacts

CONTACTBenjamin Juckett, MS
benjamin.juckett@cuanschutz.edu303-724-1338

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026