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Diabetic Kidney Disease: Influence of Exercise Therapy on Physical and Vascular Function. | Clinical Trials | Clareo Health

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

NCT02112071•University of Minnesota

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 90 years

Sex

ALL

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).
+3 more criteria

Exclusion Criteria

•• Patients are currently exercising
•* Requiring dialysis
•* Have an Hematocrit \<30%
•* Uncontrolled hypertension (\>200/100mmHg)
•* Peripheral vascular disease.

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Key Dates

Start Date

October 1, 2009

Primary Completion Date

November 1, 2012

Completion Date

October 1, 2013

Last Updated

July 24, 2015

Enrollment

122

ACTUAL participants

Conditions

Focus Type 2 Diabetes Related Chronic Kidney Disease

Interventions

Exercise

BEHAVIORAL