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

This study is currently recruiting participants.
Verified April 2013 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01036490
First received: December 17, 2009
Last updated: April 16, 2013
Last verified: April 2013
History of Changes
  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: Structured Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Structured Exercise in Obese Diabetic Patients With Chronic Kidney Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Decrease in proteinuria [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1 Other: Structured Exercise
Exercise training for 12 weeks followed by home exercise for 40 weeks

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01036490

Contacts
Contact: David J Leehey (708) 202-8387 ext 22781 David.Leehey@va.gov
Contact: Eileen G Collins, PhD RN (708) 202-3525 eileen.collins@va.gov

Locations
United States, Illinois
Edward Hines, Jr. VA Hospital Recruiting
Hines, Illinois, United States, 60141-5000
Contact: David J Leehey     708-202-8387 ext 22781     David.Leehey@va.gov    
Contact: Eileen G Collins, PhD RN     (708) 202-3525     eileen.collins@va.gov    
Principal Investigator: David J Leehey            
Sub-Investigator: Eileen G. Collins, PhD RN            
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: David J Leehey Edward Hines Jr. VA Hospital
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01036490     History of Changes
Other Study ID Numbers: F7264-R
Study First Received: December 17, 2009
Last Updated: April 16, 2013
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on May 16, 2013