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NCT Number: NCT04791371

Role of Microvascular Insulin Resistance and Cardiorespiratory Fitness Diabetes

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.

Recruiting

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Key information

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cardiovascular Exercise

Behavioral

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

Primary outcomes

  1. Change in peak oxygen consumption (VO2)

    Time frame: Through study completion, approximately 4 months

    Subjects' peak oxygen consumption will be tested on a stationary bike before and after 15 weeks of exercise

  2. Change in insulin sensitivity

    Time frame: Through study completion, approximately 4 months

    The investigators will evaluate the changes in insulin sensitivity utilizing a euglycemic insulin clamp

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin Juckett, MS

CONTACT

[email protected]

303-724-1338

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of Virginia

Registry information

Acronym: REACH

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 10, 2021
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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