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

Completed · Not applicable

Conditions studied: Focus Type 2 Diabetes Related Chronic Kidney Disease

In brief

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).

Key facts

Study ID

NCT02112071

Run by

University of Minnesota

People needed

122

Starts

2009-10-01

Expected to finish

2013-10-01

Last updated by the study team

2015-07-24

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • 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.

You may not qualify if…

• • 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.

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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