Effects of Walking and Heating on Vascular Function in Diabetic Patients

NCT ID: NCT03203694

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-04
• Study Completion Date: 2022-03-10

Brief Summary

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).

Detailed 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.

Conditions

Type 2 Diabetes Mellitus; Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Walking: Intervention arm in diabetics

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

Group Type: EXPERIMENTAL

Walking: Intervention arm in diabetics

Intervention Type: BEHAVIORAL

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 diabetics

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

Group Type: EXPERIMENTAL

Walking: No intervention in diabetics

Intervention Type: OTHER

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

Walking: Healthy cohort as reference controls

Subjects will be studied at one time only.

Group Type: OTHER

Walking: Healthy cohort as reference controls

Intervention Type: OTHER

Subjects will be studied at one time only.

Lower body heating: Intervention arm in healthy subjects

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

Group Type: EXPERIMENTAL

Lower body heating: Intervention arm in healthy subjects

Intervention Type: BEHAVIORAL

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

Lower body heating: Intervention arm in diabetics

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

Group Type: EXPERIMENTAL

Lower body heating: Intervention arm in diabetics

Intervention Type: BEHAVIORAL

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

Lower body heating: Healthy cohort as reference controls

Subjects will be studied at one time only.

Group Type: OTHER

Lower body heating: Healthy cohort as reference controls

Intervention Type: OTHER

Subjects will be studied at one time only.

Interventions

Walking: Intervention arm in diabetics

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

Intervention Type: BEHAVIORAL

Walking: No intervention in diabetics

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

Intervention Type: OTHER

Walking: Healthy cohort as reference controls

Subjects will be studied at one time only.

Intervention Type: OTHER

Lower body heating: Intervention arm in healthy subjects

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

Intervention Type: BEHAVIORAL

Lower body heating: Intervention arm in diabetics

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

Intervention Type: BEHAVIORAL

Lower body heating: Healthy cohort as reference controls

Subjects will be studied at one time only.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Jaume Padilla

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jaume Padilla, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

University of Missouri

Columbia, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Lower body heating

View Document

Document Type: Informed Consent Form: Lower body heating: Healthy cohort as reference controls

View Document

Document Type: Informed Consent Form: Walking

View Document

Other Identifiers

2008181

Identifier Type: -

Identifier Source: org_study_id