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Exercise in Obese Diabetic Patients With Chronic Kidney Disease (EX-ODCKD)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01036490
First Posted: December 21, 2009
Last Update Posted: August 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
Patients with type 2 diabetes, obesity, and chronic kidney disease are generally physically inactive, have a high mortality rate, and may benefit from an exercise program. This study seeks to determine if a structured exercise program will benefit the heart (improved exercise tolerance, decreased blood pressure) and/or the kidney (decreased protein loss in urine and stabilization of kidney function) and lead to improvements in diabetes, body composition, and quality of life.

Condition Intervention
Chronic Kidney Disease Other: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Structured Exercise in Obese Diabetic Patients With Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Change in Proteinuria [ Time Frame: 12 weeks minus baseline ]
  • Change in Proteinuria [ Time Frame: 52 weeks minus baseline ]

Secondary Outcome Measures:
  • Change in Albuminuria [ Time Frame: 12 weeks minus baseline ]
  • Change in Albuminuria [ Time Frame: 52 weeks minus baseline ]
  • Change in Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: 12 weeks minus baseline ]
  • Change in Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: 52 weeks minus baseline ]

Enrollment: 36
Actual Study Start Date: July 1, 2010
Estimated Study Completion Date: June 30, 2018
Primary Completion Date: December 31, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Control group
Experimental: Exercise
Exercise Group
Other: Exercise
Exercise training for 12 weeks followed by home exercise for 40 weeks

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetes mellitus
  • CKD Stages 2-4
  • BMI > 30
  • Persistent proteinuria (urine protein/creatinine > 200 mg/g for > 3 mo)
  • On treatment with ACE inhibitor or ARB
  • On treatment with aspirin
  • On treatment with statin (if LDL > 100)

Exclusion Criteria:

  • Symptomatic neuropathy/retinopathy
  • Positive stress test due to coronary arterial disease
  • Symptomatic cardiovascular disease
  • Congestive heart failure (New York Heart Association Class III or IV)
  • Chronic obstructive pulmonary disease (FEV1 < 50% predicted and/or requires supplemental oxygen support during exercise)
  • Complaints of angina during the stress test
  • Cerebrovascular disease/cognitive impairment
  • Renal transplant
  • Inability to walk on the treadmill
  • Any unforeseen illness or disability that would preclude exercise testing or training
  • Participation in a formal exercise program within the previous 12 weeks
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01036490


Locations
United States, Illinois
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States, 60141-5000
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: David J Leehey Edward Hines Jr. VA Hospital, Hines, IL
Principal Investigator: Eileen G. Collins, PhD RN Edward Hines Jr. VA Hospital, Hines, IL
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01036490     History of Changes
Other Study ID Numbers: F7264-R
First Submitted: December 17, 2009
First Posted: December 21, 2009
Results First Submitted: March 24, 2016
Results First Posted: April 27, 2016
Last Update Posted: August 16, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency