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Effects of Walking and Heating on Vascular Function in Diabetic Patients

Primary Purpose

Type 2 Diabetes Mellitus, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Walking
Lower body heating
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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: 35 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)

Sites / Locations

  • University of Missouri

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

Walking intervention

Control

Lower body heating

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Endothelial function
Measure of flow-mediated dilation
Leg blood flow
Measure of blood flow
Blood glucose
Measure of blood glucose
Plasma insulin
Measure of plasma insulin

Secondary Outcome Measures

Full Information

First Posted
June 23, 2017
Last Updated
May 19, 2022
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT03203694
Brief Title
Effects of Walking and Heating on Vascular Function in Diabetic Patients
Official Title
Restoring Vasodilator Actions of Insulin in Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 4, 2017 (Actual)
Primary Completion Date
March 10, 2022 (Actual)
Study Completion Date
March 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be assigned to either a walking, a lower body heating, or no intervention.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Walking intervention
Arm Type
Experimental
Arm Description
The walking program will consist of 45 minutes of walking (at a moderate pace) 5 days per week for 8 weeks.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Subjects will be instructed to continue their usual lifestyle for 8 weeks.
Arm Title
Lower body heating
Arm Type
Experimental
Arm Description
This intervention consists of 60 minutes of lower body heating (40-42 degree C) 7 days per week for 7 days.
Intervention Type
Behavioral
Intervention Name(s)
Walking
Intervention Description
The walking program will consist of 45 minutes of walking (at a moderate pace) 5 days per week for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Lower body heating
Intervention Description
This intervention consists of 60 minutes of lower body heating (40-42 degree C) 7 days per week for 7 days.
Primary Outcome Measure Information:
Title
Endothelial function
Description
Measure of flow-mediated dilation
Time Frame
Change from baseline flow-mediated dilation at 7 days (heating intervention) or 8 weeks (exercise intervention)
Title
Leg blood flow
Description
Measure of blood flow
Time Frame
Change from baseline insulin-stimulated leg blood flow at 7 days (heating intervention) or 8 weeks (exercise intervention)
Title
Blood glucose
Description
Measure of blood glucose
Time Frame
Change from baseline blood glucose at 7 days (heating intervention) or 8 weeks (exercise intervention)
Title
Plasma insulin
Description
Measure of plasma insulin
Time Frame
Change from baseline plasma insulin at 7 days (heating intervention) or 8 weeks (exercise intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: 35 to 65 years of age. Exclusion Criteria: Cardiovascular disease including myocardial infraction, heart failure, coronary artery disease, stroke; renal or hepatic diseases; active cancer; autoimmune diseases; immunosuppressant therapy; excessive alcohol consumption (>14 drinks/week for men; >7 drinks/week for women); current tobacco use; pregnancy; mobility limitations; foot ulcers; diabetic neuropathy uncontrolled hypertension (>=180 systolic / 100 diastolic mmHg)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaume Padilla, PhD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Walking and Heating on Vascular Function in Diabetic Patients

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