Combined Diabetes-Renal Multifactorial Intervention In Patients With Advanced Diabetic Nephropathy (ADN)
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional

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 in subjects treated by multi-factorial intervention in the Diabetes-Renal
      Clinic.
    

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 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.
    

Intervention name(s): Multifactorial Intervention
Intervention type(s): Other
Intervention description(s): Study group will receive multifactorial intervention for advanced diabetic nephropathy:
Elements of multifactorial intervention:
BP control of <130/80mmHg and renal protection with reduction of proteinuria to <0.5g/day using therapy with ACE inhibitors and/or ARBs.
Tight glucose control with target of HbA1C of 7% and below using SMBG and Lantus/Apidra regimen.
Use of hypolipidemic therapy to achieve targets of LDL < 70 mg/dl, HDL > 40/50 mg/dl (M/F)and TG < 200 mg/dl.
Patient enhanced self-management provided by combined diabetes-renal education curriculum.
Behavior and social intervention
Intense case management that includes close follow-up of visits, laboratory monitoring and other self-adherence behaviors carried out by clinical research coordinators.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetic Nephropathy