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



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 90
Updated:4/21/2016
Start Date:October 2009
End Date:October 2013

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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).


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.
We found this trial at
1
site
Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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