Status:
COMPLETED
Combined Diabetes-Renal Multifactorial Intervention In Patients With Advanced Diabetic Nephropathy (ADN)
Lead Sponsor:
Cook County Health
Collaborating Sponsors:
Sanofi
Conditions:
Diabetic Nephropathy
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The purpose of this study is to compare the progression of kidney disease in subjects with Diabetes mellitus type 2 and Advanced Diabetic Nephropathy treated by routine follow-up as a general care and...
Detailed Description
In this study, the overall objective is comparison of progression of renal insufficiency in subjects with Advanced Diabetic Nephropathy (CKD stages 3 and 4) randomized into multifactorial intervention...
Eligibility Criteria
Inclusion
- The participant is male or female diagnosed with Type 2 Diabetes mellitus defined by the American Diabetes Association criteria and must be aged 18 to 70 years.
- The participant must have documented Advanced Diabetic Nephropathy (ADN) defined as presence of proteinuria or micro/macro-albuminuria and impaired GFR (by MDRD equation) corresponding to Chronic Kidney Disease (CKD) stages 3-4 (moderate-severe i.e. estimated GFR \>15ml/min and \<60ml/min).
- A. Presence of macroalbuminuria B. Presence of microalbuminuria if no therapy with ACE inhibitors or ARBs C. Presence of current microalbuminuria and previous documentation of macroalbuminuria D. Presence of current microalbuminuria and previous documentation of Diabetic Retinopathy or laser therapy E. If only microalbuminuria and no A, B, C or D US of kidney shows NL size.
- Minimal cognitive function for a diabetes self management
- Fasting or random Blood glucose \<400mg/DL
Exclusion
- Patients with Type 1 Diabetes Mellitus.
- Serum Creatinine \> 4.0 mg/dl and/or an estimated GFR of \< 15 ml/min.
- Patients on renal replacement therapy.
- Patients with Hyperkalemia (K\>5.0 meq/L).
- Patients with known Renal Artery stenosis.
- Patients with known cancer, hepatic impairment, dementia or other chronic medical diseases.
- Patients with severe heart failure (NYHA Class III or IV symptoms and/or LVEF \<25%).
- Patients with valvular or outflow tract obstruction.
- Patients with significant disability that precludes regular attendance at clinics for follow-up.
- Patients unwilling or unable to provide informed consent.
- Pregnant or lactating women.
- Current addiction to substance or alcohol abuse.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00708981
Start Date
May 1 2007
End Date
December 1 2013
Last Update
August 26 2024
Active Locations (1)
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1
John H. Stroger Jr. Hospital of Cook County
Chicago, Illinois, United States, 60612