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CompletedNCT02112071DKD-EXTUpdated Jul 24, 2015

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

An interventional study of Exercise in Focus Type 2 Diabetes Related Chronic Kidney Disease, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2015-07-24.

Sponsored by University of Minnesota · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
122
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Focus Type 2 Diabetes Related Chronic Kidney Disease

Keywords

  • Exercise
  • Diabetic kidney disease
  • vascular function
  • physical function
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 122 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
122 participants (actual)

Study arms

  • Experimental
    Exercise

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

    Behavioral: Exercise

  • No intervention
    control

    control group asked to continue usual activities

Interventions

  • BehavioralExercise

    Blended supervised-home based walking program 3-4 times per week for at least 30 minutes.

06

What researchers measure

Primary outcomes

  1. endothelial function measured by brachial artery flow mediated vasodilation

    Endothelium-mediated change in in vascular tone

    Time frame: at week 0 and at week 12

Secondary outcomes

  1. arterial stiffness measured by pulse wave velocity

    Time frame: at week 0 and at week 12

  2. Circulating markers of vascular health

    C-reactive protein, isoprostane F2, Asymmetric dimethylarginine

    Time frame: at week 0 and at week 12

  3. aerobic capacity

    Peak oxygen consumption

    Time frame: at week 0 and at week 12

  4. blood pressure

    Time frame: at week 0 and at week 12

  5. 24-hour albuminuria

    assessed in 30 participants measured in milligram per gram creatinine

    Time frame: at week 0 and at week 12

07

Study locations

1 site
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02112071
Lead sponsor
University of Minnesota
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Sponsor
First posted
Apr 11, 2014
Start date
Oct 2009
Primary completion
Nov 2012
Completion
Oct 2013
Last update
Jul 24, 2015

Study contacts

Ulf G Bronas, PhD
principal investigator · University of Minnesota

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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