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

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).

Study Overview

• Status: Completed
• Conditions: Focus Type 2 Diabetes Related Chronic Kidney Disease
• Intervention / Treatment: Behavioral: Exercise

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise; blended supervised-hombased exercise training 3-4 times/week for 12 weeks	Behavioral: Exercise; Blended supervised-home based walking program 3-4 times per week for at least 30 minutes.
No Intervention: control; control group asked to continue usual activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
endothelial function measured by brachial artery flow mediated vasodilation	Endothelium-mediated change in in vascular tone	at week 0 and at week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
arterial stiffness measured by pulse wave velocity		at week 0 and at week 12
Circulating markers of vascular health	C-reactive protein, isoprostane F2, Asymmetric dimethylarginine	at week 0 and at week 12
aerobic capacity	Peak oxygen consumption	at week 0 and at week 12
blood pressure		at week 0 and at week 12
24-hour albuminuria	assessed in 30 participants measured in milligram per gram creatinine	at week 0 and at week 12

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Ulf G Bronas, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: April 9, 2014
• First Submitted That Met QC Criteria: April 9, 2014
• First Posted (Estimate): April 11, 2014

Study Record Updates

• Last Update Posted (Estimate): July 24, 2015
• Last Update Submitted That Met QC Criteria: July 23, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Exercise; Diabetic kidney disease; vascular function; physical function
• Additional Relevant MeSH Terms: Urologic Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Diabetic Nephropathies
• Other Study ID Numbers: 0905M66282; K23DK082638-04 (U.S. NIH Grant/Contract); 22275 (Other Identifier: University of Minnesota)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No