Role of Microvascular Insulin Resistance and Cardiorespiratory Fitness Diabetes

NCT ID: NCT04791371

Last Updated: 2025-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-17

Study Completion Date

2027-12-01

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Overweight and Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Type 2 Diabetes

Participants aged 30-55 with type 2 diabetes

Group Type EXPERIMENTAL

Cardiovascular exercise

Intervention Type BEHAVIORAL

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

Healthy overweight control

Participants aged 30-55 with BMI 25-40 without type 2 diabetes

Group Type EXPERIMENTAL

Cardiovascular exercise

Intervention Type BEHAVIORAL

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

Interventions

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Cardiovascular exercise

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Virginia

OTHER

Sponsor Role collaborator

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

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Colorado

Aurora, Colorado, United States

Site Status RECRUITING

University of Virginia

Charlottesville, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Benjamin Juckett, MS

Role: CONTACT

303-724-1338

Facility Contacts

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Benjamin Juckett, MS

Role: primary

303-724-1338

Ethan Clark, MS

Role: backup

303-724-1354

Lee Hartline, MEd

Role: primary

434-924-5247

Linda Jahn, RN

Role: backup

434-924-1134

Other Identifiers

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R01DK124344

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-2723

Identifier Type: -

Identifier Source: org_study_id

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