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

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.
ClinicalTrials.gov Identifier: NCT01036490
Recruitment Status : Active, not recruiting
First Posted : December 21, 2009
Results First Posted : April 27, 2016
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Chronic Kidney Disease Other: Exercise

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
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
Actual Study Start Date : July 1, 2010
Primary Completion Date : December 31, 2014
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: Control
Control group
Experimental: Exercise
Exercise Group
Other: Exercise
Exercise training for 12 weeks followed by home exercise for 40 weeks


Outcome Measures

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

Secondary Outcome Measures :
  1. Change in Albuminuria [ Time Frame: 12 weeks minus baseline ]
  2. Change in Albuminuria [ Time Frame: 52 weeks minus baseline ]
  3. Change in Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: 12 weeks minus baseline ]
  4. Change in Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: 52 weeks minus baseline ]

Eligibility Criteria

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 Posted: December 21, 2009    Key Record Dates
Results First Posted: April 27, 2016
Last Update Posted: December 8, 2017
Last Verified: December 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