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Diabetic Kidney Disease: Influence of Exercise Therapy on Physical and Vascular Function. (DKD-EXT)

Primary Purpose

Focus Type 2 Diabetes Related Chronic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Focus Type 2 Diabetes Related Chronic Kidney Disease focused on measuring Exercise, Diabetic kidney disease, vascular function, physical function

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • An individual must be >18 years of age

Have diagnosed type 2 diabetic mellitus by one of the following criteria:

o Treated with diet, diet plus oral hypoglycemic agents (for at least one year), or insulin preceded by treatment with oral agents (for at least one year).

If treated with insulin, the onset of diabetes must have occurred after age of 40 and the body mass index must be >25kg/m2 at the time of diagnosis.

Diagnosed kidney attributed to diabetes by one of the following criteria:3

  • Macroalbuminuria (ACR >300mg/g, or)
  • Microalbuminuria (ACR between 30-300 mg/g) or in the presence of diabetic retinopathy (although is recognized that about 1/3 of type 2 diabetics do not have retinopathy by fundoscopic exam).
  • An elevated ACR should have been confirmed in the absence of urinary tract infections with 2 additional first-void specimens collected over 3-6 months.

  • At least 2 of 3 samples should fall within the range of micro or macroalbuminuria.

    • An estimated Glomerular filtration rate (GFR) of between 90 ml/min and 30 ml/min measured by (GFR (mL/min/1.73 m2) = 186 x (Scr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.210 if African-American) (conventional units).
    • Individuals must be able to provide informed consent
    • Perform walking exercise testing on a treadmill
    • Be able to participate in a 12-week supervised exercise program.

Exclusion Criteria:

  • • Patients are currently exercising

    • Requiring dialysis
    • Have an Hematocrit <30%
    • Uncontrolled hypertension (>200/100mmHg)
    • Peripheral vascular disease.
    • An inability to understand English or give consent. Other exclusion criteria are: any contraindications to exercise testing or training as indicated by the American College of Sports Medicine guidelines such as: Unstable coronary heart disease and symptomatic heart failure, exercise capacity limited by health problems such as angina, severe arthritis, or extreme dyspnea on exertion, progressive neuromuscular disease, pulmonary disease., or having undergone a coronary revascularization within the past 6 months prior to enrollment.

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise

control

Arm Description

blended supervised-hombased exercise training 3-4 times/week for 12 weeks

control group asked to continue usual activities

Outcomes

Primary Outcome Measures

endothelial function measured by brachial artery flow mediated vasodilation
Endothelium-mediated change in in vascular tone

Secondary Outcome Measures

arterial stiffness measured by pulse wave velocity
Circulating markers of vascular health
C-reactive protein, isoprostane F2, Asymmetric dimethylarginine
aerobic capacity
Peak oxygen consumption
blood pressure
24-hour albuminuria
assessed in 30 participants measured in milligram per gram creatinine

Full Information

First Posted
April 9, 2014
Last Updated
July 23, 2015
Sponsor
University of Minnesota
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT02112071
Brief Title
Diabetic Kidney Disease: Influence of Exercise Therapy on Physical and Vascular Function.
Acronym
DKD-EXT
Official Title
Diabetic Kidney Disease: Influence of Exercise Therapy on Physical and Vascular Function.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The general objective is to investigate the effect of a 12 week walking exercise program on vascular endothelial function, arterial stiffness/compliance, and vascular health biomarkers in men and women with pre-dialysis type 2 diabetic kidney disease (DKD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focus Type 2 Diabetes Related Chronic Kidney Disease
Keywords
Exercise, Diabetic kidney disease, vascular function, physical function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
blended supervised-hombased exercise training 3-4 times/week for 12 weeks
Arm Title
control
Arm Type
No Intervention
Arm Description
control group asked to continue usual activities
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Blended supervised-home based walking program 3-4 times per week for at least 30 minutes.
Primary Outcome Measure Information:
Title
endothelial function measured by brachial artery flow mediated vasodilation
Description
Endothelium-mediated change in in vascular tone
Time Frame
at week 0 and at week 12
Secondary Outcome Measure Information:
Title
arterial stiffness measured by pulse wave velocity
Time Frame
at week 0 and at week 12
Title
Circulating markers of vascular health
Description
C-reactive protein, isoprostane F2, Asymmetric dimethylarginine
Time Frame
at week 0 and at week 12
Title
aerobic capacity
Description
Peak oxygen consumption
Time Frame
at week 0 and at week 12
Title
blood pressure
Time Frame
at week 0 and at week 12
Title
24-hour albuminuria
Description
assessed in 30 participants measured in milligram per gram creatinine
Time Frame
at week 0 and at week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • An individual must be >18 years of age Have diagnosed type 2 diabetic mellitus by one of the following criteria: o Treated with diet, diet plus oral hypoglycemic agents (for at least one year), or insulin preceded by treatment with oral agents (for at least one year). If treated with insulin, the onset of diabetes must have occurred after age of 40 and the body mass index must be >25kg/m2 at the time of diagnosis. Diagnosed kidney attributed to diabetes by one of the following criteria:3 Macroalbuminuria (ACR >300mg/g, or) Microalbuminuria (ACR between 30-300 mg/g) or in the presence of diabetic retinopathy (although is recognized that about 1/3 of type 2 diabetics do not have retinopathy by fundoscopic exam). An elevated ACR should have been confirmed in the absence of urinary tract infections with 2 additional first-void specimens collected over 3-6 months. At least 2 of 3 samples should fall within the range of micro or macroalbuminuria. An estimated Glomerular filtration rate (GFR) of between 90 ml/min and 30 ml/min measured by (GFR (mL/min/1.73 m2) = 186 x (Scr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.210 if African-American) (conventional units). Individuals must be able to provide informed consent Perform walking exercise testing on a treadmill Be able to participate in a 12-week supervised exercise program. Exclusion Criteria: • Patients are currently exercising Requiring dialysis Have an Hematocrit <30% Uncontrolled hypertension (>200/100mmHg) Peripheral vascular disease. An inability to understand English or give consent. Other exclusion criteria are: any contraindications to exercise testing or training as indicated by the American College of Sports Medicine guidelines such as: Unstable coronary heart disease and symptomatic heart failure, exercise capacity limited by health problems such as angina, severe arthritis, or extreme dyspnea on exertion, progressive neuromuscular disease, pulmonary disease., or having undergone a coronary revascularization within the past 6 months prior to enrollment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulf G Bronas, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

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Diabetic Kidney Disease: Influence of Exercise Therapy on Physical and Vascular Function.

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