Recruiting

Exercise Training

Sponsor:

University of Colorado, Denver

Code:

NCT04791371

Conditions

Type 2 Diabetes

Overweight and Obesity

Eligibility Criteria

Sex: All

Age: 30 - 55

Healthy Volunteers: Accepted

Interventions

Cardiovascular exercise

Study Details

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.

Conditions

Type 2 Diabetes

Overweight and Obesity

Study ID

NCT04791371

Start date

Jun 17, 2022

Status verified date

Mar, 2026

Completion date

Feb 15, 2027

Anticipated

Primary completion date

Jan 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 55

Healthy Volunteers: Accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Type 2 Diabetes

Participants aged 30-55 with type 2 diabetes

experimental: Healthy overweight control

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

Interventions

Cardiovascular exercise

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

Primary outcome measure

  • Change in peak oxygen consumption (VO2) [ Time Frame: Through study completion, approximately 4 months ]
  • Change in insulin sensitivity [ Time Frame: Through study completion, approximately 4 months ]

Central Contacts and Locations

Central contacts

Benjamin Juckett, MS

303-724-1338benjamin.juckett@cuanschutz.edu

Locations

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Benjamin Juckett, MS

303-724-1338benjamin.juckett@cuanschutz.edu

Ethan Clark, MS

303-724-1354ethan.w.clark@cuanschutz.edu

Principal Investigator:

Judy Regensteiner, PhD

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Lee Hartline, MEd

434-924-5247lmh9d@virginia.edu

Linda Jahn, RN

434-924-1134las6e@virginia.edu

Principal Investigator:

Zhenqi Liu, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-03-23.