Clinical trial NCT04791371: Role of Microvascular Insulin Resistance and Cardiorespiratory Fitness Diabetes
Official title: Role of Microvascular Insulin Resistance and Cardiorespiratory Fitness Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Overweight and Obesity
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: University of Virginia
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-03-10
Enrollment: 150
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in peak oxygen consumption (VO2)
timeFrame: Through study completion, approximately 4 months
measure: Change in insulin sensitivity
timeFrame: Through study completion, approximately 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References: