Effects of Walking and Heating on Vascular Function in Diabetic Patients

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus; Obesity

• Registration Number: NCT03203694
• Lead Sponsor: University of Missouri-Columbia

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.

Study Timeline

• Study First Submitted: 2017-06-23
• Study First Submitted QC: 2017-06-26
• Study First Posted: 2017-06-29
• Study Start: 2017-12-04
• Primary Completion: 2022-03-10
• Study Completion: 2022-03-10
• Results First Submitted: 2023-09-28
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-01
• Last Update Submitted: 2024-04-01
• Results First Posted: 2024-04-04
• Last Update Posted: 2024-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Insulin-stimulated Leg Blood Flow Calculated as Percent Change (t0, t60)	Percent change from baseline leg blood flow during 60 minutes of insulin stimulation.	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).
Net Change in Insulin-stimulated Leg Blood Flow Calculated as Percent Change From Pre-intervention (t0,t60) to Post-intervention (t0,t60).	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.	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.

Trial Locations

Locations (1)

University of Missouri; 🇺🇸 Columbia, Missouri, United States