NCT00708981

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Cook County Health · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Nephropathy

Interventions

Type	Name	Description
OTHER	Multifactorial Intervention	Study group will receive multifactorial intervention for advanced diabetic nephropathy: Elements of multifactorial intervention: 1. BP control of \<130/80mmHg and renal protection with reduction of proteinuria to \<0.5g/day using therapy with ACE inhibitors and/or ARBs. 2. Tight glucose control with target of HbA1C of 7% and below using SMBG and Lantus/Apidra regimen. 3. Use of hypolipidemic therapy to achieve targets of LDL \< 70 mg/dl, HDL \> 40/50 mg/dl (M/F)and TG \< 200 mg/dl. 4. Patient enhanced self-management provided by combined diabetes-renal education curriculum. 5. Behavior and social intervention 6. Intense case management that includes close follow-up of visits, laboratory monitoring and other self-adherence behaviors carried out by clinical research coordinators.

Timeline

• Start date: 2007-05-01
• Primary completion: 2013-10-01
• Completion: 2013-12-01
• First posted: 2008-07-03
• Last updated: 2024-08-26

Locations

1 site across 1 country: United States