Role of Microvascular Insulin Resistance and Cardiorespiratory Fitness Diabetes (REACH)

January 31, 2024 updated by: University of Colorado, Denver
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado
        • Principal Investigator:
          • Judy Regensteiner, PhD
        • Principal Investigator:
          • Jane Reusch, MD
        • Contact:
        • Contact:
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia
        • Contact:
        • Principal Investigator:
          • Zhenqi Liu, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Type 2 Diabetes
Participants aged 30-55 with type 2 diabetes
Behavioral: Cardiovascular exercise
15 weeks of cardiovascular exercise 3x/week for 50 minutes/session
Experimental: Healthy overweight control
Participants aged 30-55 with BMI 25-40 without type 2 diabetes
Behavioral: Cardiovascular exercise
15 weeks of cardiovascular exercise 3x/week for 50 minutes/session

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, approximately 4 months
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
Through study completion, approximately 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2022

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 8, 2021

First Submitted That Met QC Criteria

March 8, 2021

First Posted (Actual)

March 10, 2021

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-2723
  • R01DK124344 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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