Effects of Walking and Heating on Vascular Function in Diabetic Patients

University of Missouri (MU)

Status: Completed

Conditions: Type 2 Diabetes Mellitus; Obesity

Treatments: Behavioral: Lower body heating: Intervention arm in healthy subjects; Behavioral: Lower body heating: Intervention arm in diabetics; Behavioral: Walking: Intervention arm in diabetics; Other: Walking: No intervention in diabetics; Other: Walking: Healthy cohort as reference controls; Other: Lower body heating: Healthy cohort as reference controls

Study type: Interventional

Funder types: Other

Identifiers

NCT03203694

2008181

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 99 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

99 participants in 6 patient groups

Walking: Intervention arm in diabetics

Experimental group

Description:

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

Treatment:

Behavioral: Walking: Intervention arm in diabetics

Walking: No intervention in diabetics

Experimental group

Description:

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

Treatment:

Other: Walking: No intervention in diabetics

Walking: Healthy cohort as reference controls

Other group

Description:

Subjects will be studied at one time only.

Treatment:

Other: Walking: Healthy cohort as reference controls

Lower body heating: Intervention arm in healthy subjects

Experimental group

Description:

This intervention consists of 60 minutes of lower body heating (40-42 degree C).

Treatment:

Behavioral: Lower body heating: Intervention arm in healthy subjects

Lower body heating: Intervention arm in diabetics

Experimental group

Description:

This intervention consists of 60 minutes of lower body heating (40-42 degree C) 7 days per week for 7 days.

Treatment:

Behavioral: Lower body heating: Intervention arm in diabetics

Lower body heating: Healthy cohort as reference controls

Other group

Description:

Subjects will be studied at one time only.

Treatment:

Other: Lower body heating: Healthy cohort as reference controls