MedTrace Logo

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

NCT00708981 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-08-26

No results posted yet for this study

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.

Conditions

  • Diabetic Nephropathy

Interventions

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.

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Cook County Health

    lead OTHER_GOV

Principal Investigators

  • Leon Fogelfeld, MD · John H. Stroger, Jr. Hospital of Cook County, Endocrinology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2013-10-31
Completion
2013-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00708981 on ClinicalTrials.gov