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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01036490
First received: December 17, 2009
Last updated: April 27, 2016
Last verified: April 2016
  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
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:


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

Primary Outcome Measures:
  • Change in Proteinuria [ Time Frame: 12 weeks minus baseline ] [ Designated as safety issue: No ]
  • Change in Proteinuria [ Time Frame: 52 weeks minus baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Albuminuria [ Time Frame: 12 weeks minus baseline ] [ Designated as safety issue: No ]
  • Change in Albuminuria [ Time Frame: 52 weeks minus baseline ] [ Designated as safety issue: No ]
  • Change in Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: 12 weeks minus baseline ] [ Designated as safety issue: No ]
  • Change in Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: 52 weeks minus baseline ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: July 2010
Estimated Study Completion Date: June 2016
Primary Completion Date: December 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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: December 17, 2009
Results First Received: March 24, 2016
Last Updated: April 27, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on July 21, 2016