Role of Microvascular Insulin Resistance and Cardiorespiratory Fitness Diabetes

Type 2 Diabetes Clinical Trial

— REACH  

Official title:

Role of Microvascular Insulin Resistance and Cardiorespiratory Fitness Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04791371
• Other study ID #: 20-2723
• Secondary ID: R01DK124344
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2022
• Est. completion date: December 1, 2027

Study information

• Verified date: January 2024
• Source: University of Colorado, Denver
• Contact: Benjamin Juckett, MS
• Phone: 303-724-1338
• Email: benjamin.juckett[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 1, 2027
• Est. primary completion date: December 15, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Insulin Resistance
• Overweight
• Overweight and Obesity
• Type 2 Diabetes

Intervention

Behavioral:
• Cardiovascular exercise
15 weeks of cardiovascular exercise 3x/week for 50 minutes/session

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado
United States	University of Virginia	Charlottesville	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in peak oxygen consumption (VO2)	Subjects' peak oxygen consumption will be tested on a stationary bike before and after 15 weeks of exercise	Through study completion, approximately 4 months
Primary	Change in insulin sensitivity	The investigators will evaluate the changes in insulin sensitivity utilizing a euglycemic insulin clamp	Through study completion, approximately 4 months