Effects of Walking and Heating on Vascular Function in Diabetic Patients

N/ACompletedNCT03203694

University of Missouri-Columbia99 enrolled

Overview

The purpose of the present study is to determine the effects of increased walking and lower body heating on leg vascular function in patients with type 2 diabetes (T2D).

The notion that habitual aerobic exercise increases insulin-induced vasodilation is largely founded on rodent studies, hence the urgent need for human studies, especially in patients with type 2 diabetes (T2D). For example, it remains unknown if increased walking, the most common form of physical activity, enhances skeletal muscle vasodilator actions of insulin in T2D. In addition, the molecular mechanisms by which exercise improves vasoreactivity to insulin have not been examined in humans. The investigators propose that in T2D patients who are sedentary (i.e., the vast majority), increased leg blood flow with walking or local heating signifies a vital strategy to correct vascular insulin resistance. This study will establish whether increased physical activity and associated hemodynamic forces (e.g., shear stress) are a direct form of vascular medicine in humans.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus Obesity

Interventions

Walking: Intervention arm in diabeticsBEHAVIORAL

The walking program will consist of 45 minutes of walking (at a moderate pace) 5 days per week for 8 weeks.

Walking: No intervention in diabeticsOTHER

Subjects will be instructed to continue their usual lifestyle for 8 weeks.

Walking: Healthy cohort as reference controlsOTHER

Subjects will be studied at one time only.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Patients with type 2 diabetes who are overweight and obese (BMI 25-50 kg/m2), 35 to 65 years of age, and sedentary (\<60 minutes structured exercise/week). Healthy volunteers without type 2 diabetes: 18 to 65 years of age. Exclusion Criteria: 1. Cardiovascular disease including myocardial infraction, heart failure, coronary artery disease, stroke; 2. renal or hepatic diseases; 3. active cancer; 4. autoimmune diseases; 5. immunosuppressant therapy; 6. excessive alcohol consumption (\>14 drinks/week for men; \>7 drinks/week for women); 7. current tobacco use; 8. pregnancy; 9. mobility limitations; 10. foot ulcers; 11. diabetic neuropathy 12. uncontrolled hypertension (\>=180 systolic / 100 diastolic mmHg)

Locations (1)

University of Missouri

Columbia, Missouri, United States

Outcomes

Primary Outcomes

Insulin-stimulated Leg Blood Flow Calculated as Percent Change (t0, t60)

Measure of blood flow in response to insulin. Blood flow is measured via Doppler ultrasound at the femoral artery. Measurements are performed at baseline (t0) and after 60 minutes of insulin stimulation (t60).

Time frame: Percent change from baseline leg blood flow during 60 minutes of insulin stimulation.

Net Change in Insulin-stimulated Leg Blood Flow Calculated as Percent Change From Pre-intervention (t0,t60) to Post-intervention (t0,t60).

Measure of blood flow in response to insulin. Blood flow is measured via Doppler ultrasound at the femoral artery. Measurements are performed pre-intervention and post-intervention at baseline (t0) and after 60 minutes of insulin stimulation (t60). Outcome measure indicates whether percent change in insulin-stimulated blood flow increased or decreased following intervention. Interventions that show an increase demonstrate an improvement in insulin-stimulated blood flow.

Time frame: Change from baseline insulin-stimulated leg blood flow following 1 heating session, 7 days of heating intervention, or 8 weeks of walking intervention/no intervention.

Data from ClinicalTrials.gov

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