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Completed

NCT Number: NCT02112071

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

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).

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Behavioral

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

Primary outcomes

  1. endothelial function measured by brachial artery flow mediated vasodilation

    Time frame: at week 0 and at week 12

    Endothelium-mediated change in in vascular tone

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

    Time frame: at week 0 and at week 12

    C-reactive protein, isoprostane F2, Asymmetric dimethylarginine

  3. aerobic capacity

    Time frame: at week 0 and at week 12

    Peak oxygen consumption

  4. blood pressure

    Time frame: at week 0 and at week 12

  5. 24-hour albuminuria

    Time frame: at week 0 and at week 12

    assessed in 30 participants measured in milligram per gram creatinine

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: DKD-EXT

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Apr 11, 2014
Registry last updated
Jul 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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