Combined Diabetes-Renal Multifactorial Intervention In Patients With Advanced Diabetic Nephropathy (ADN)

Not Applicable

Completed

• Conditions: Diabetic Nephropathy

• Registration Number: NCT00708981
• Lead Sponsor: Cook County Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-6-26
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Inclusion Criteria:<br><br> 1. The participant is male or female diagnosed with Type 2 Diabetes mellitus defined by<br> the American Diabetes Association criteria and must be aged 18 to 70 years.<br><br> 2. The participant must have documented Advanced Diabetic Nephropathy (ADN) defined as<br> presence of proteinuria or micro/macro-albuminuria and impaired GFR (by MDRD<br> equation) corresponding to Chronic Kidney Disease (CKD) stages 3-4 (moderate-severe<br> i.e. estimated GFR >15ml/min and <60ml/min).<br><br> A. Presence of macroalbuminuria B. Presence of microalbuminuria if no therapy with<br> ACE inhibitors or ARBs C. Presence of current microalbuminuria and previous<br> documentation of macroalbuminuria D. Presence of current microalbuminuria and<br> previous documentation of Diabetic Retinopathy or laser therapy E. If only<br> microalbuminuria and no A, B, C or D US of kidney shows NL size.<br><br> 3. Minimal cognitive function for a diabetes self management<br><br> 4. Fasting or random Blood glucose <400mg/DL<br><br>Exclusion Criteria:<br><br> 1. Patients with Type 1 Diabetes Mellitus.<br><br> 2. Serum Creatinine > 4.0 mg/dl and/or an estimated GFR of < 15 ml/min.<br><br> 3. Patients on renal replacement therapy.<br><br> 4. Patients with Hyperkalemia (K>5.0 meq/L).<br><br> 5. Patients with known Renal Artery stenosis.<br><br> 6. Patients with known cancer, hepatic impairment, dementia or other chronic medical<br> diseases.<br><br> 7. Patients with severe heart failure (NYHA Class III or IV symptoms and/or LVEF <25%).<br><br> 8. Patients with valvular or outflow tract obstruction.<br><br> 9. Patients with significant disability that precludes regular attendance at clinics<br> for follow-up.<br><br> 10. Patients unwilling or unable to provide informed consent.<br><br> 11. Pregnant or lactating women.<br><br> 12. Current addiction to substance or alcohol abuse.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Delay in development in end-stage renal failure in subjects with Advanced Diabetic Nephropathy (CKD stages 3 and 4)