Combined Diabetes-Renal Multifactorial Intervention In Patients With Advanced Diabetic Nephropathy (ADN)
Combined Diabetes-Renal Multifactorial Intervention In Patients With Advanced Diabetic Nephropathy (ADN)
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 in subjects treated by multi-factorial intervention in the Diabetes-Renal
 Clinic.
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 in the Diabetes-Renal Clinic (study group) and into usual care
 (control group). The multifactorial intervention includes the following: 1. Blood pressure
 control to the goal of <130/80mmHg and renal protection with reduction of proteinuria to
 <0.5g/day using a protocol that includes therapy with ACE inhibitors, ARBs or their
 combination. 2. Tight glucose control using SMBG and Lantus/Apidra self-escalation regimen.
 3. Use of hypolipidemic therapy to achieve targets of LDL of < 70 mg/dl, HDL > 40/50 mg/dl
 (males/females) [since you said that HDL is not a target because there are no meds for it I
 deleted HDL;] and triglycerides of less than 200 mg/dl. 4. Patient enhanced self-management
 provided by combined diabetes-renal education curriculum (taught by certified diabetes and
 renal educators). 5. Behavior and social intervention (motivational interviews and social
 assessment) provided as needed by social workers. 6. Intense case management that includes
 close follow-up of visits, laboratory monitoring and other self-adherence behaviors. 7.
 Weight loss with lifestyle and diet modification.

 Control Group will keep on receiving the usual treatment that they used to receive from their
 respective clinics and the Diabetes-Renal team would not alter their therapy or interfere in
 their management.
Inclusion Criteria:

 1. 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.

 2. 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.

 3. Minimal cognitive function for a diabetes self management

 4. Fasting or random Blood glucose <400mg/DL

 Exclusion Criteria:

 1. Patients with Type 1 Diabetes Mellitus.

 2. Serum Creatinine > 4.0 mg/dl and/or an estimated GFR of < 15 ml/min.

 3. Patients on renal replacement therapy.

 4. Patients with Hyperkalemia (K>5.0 meq/L).

 5. Patients with known Renal Artery stenosis.

 6. Patients with known cancer, hepatic impairment, dementia or other chronic medical
 diseases.

 7. Patients with severe heart failure (NYHA Class III or IV symptoms and/or LVEF <25%).

 8. Patients with valvular or outflow tract obstruction.

 9. Patients with significant disability that precludes regular attendance at clinics for
 follow-up.

 10. Patients unwilling or unable to provide informed consent.

 11. Pregnant or lactating women.

 12. Current addiction to substance or alcohol abuse.