N/A
Completed N=36
Exercise in Obese Diabetic Patients With Chronic Kidney Disease
Source: ClinicalTrials.gov NCT01036490 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcomePrimary: Change in Proteinuria — -34; -133 mg/g creatinine — p=0.04
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Proteinuria |
15; -66 | 0.39 |
| SECONDARY Change in Albuminuria |
-13; -31 | — |
| SECONDARY Change in Estimated Glomerular Filtration Rate (eGFR) |
-2.0; -3.1 | 0.58 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01036490). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.