Effects of Walking and Heating on Vascular Function in Diabetic Patients

Obesity Clinical Trial

Official title:

Restoring Vasodilator Actions of Insulin in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03203694
• Other study ID #: 2008181
• Status: Completed
• Phase: N/A
• Start date: December 4, 2017
• Est. completion date: March 10, 2022

Study information

• Verified date: April 2024
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: March 10, 2022
• Est. primary completion date: March 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• 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.

Other:
• Walking: No intervention in diabetics
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.

Behavioral:
• Lower body heating: Intervention arm in healthy subjects
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.

Other:
• Lower body heating: Healthy cohort as reference controls
Subjects will be studied at one time only.

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Percent change from baseline leg blood flow during 60 minutes of insulin stimulation.
Primary	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.	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.