Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Combined Diabetes-Renal Multifactorial Intervention In Patients With Advanced Diabetic Nephropathy (ADN)
This study is currently recruiting participants.
Verified by John H. Stroger Hospital, July 2008
Sponsors and Collaborators: John H. Stroger Hospital
Sanofi-Aventis
Information provided by: John H. Stroger Hospital
ClinicalTrials.gov Identifier: NCT00708981
  Purpose

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.


Condition Intervention Phase
Diabetic Nephropathy
 Other: Multifactorial Intervention
 Phase IV

MedlinePlus related topics: Diabetes Diabetic Kidney Problems
Drug Information available for: Insulin glargine Dextrose Insulin glulisine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title: Combined Diabetes-Renal Multifactorial Intervention In Patients With Advanced Diabetic Nephropathy (ADN)

Further study details as provided by John H. Stroger Hospital:

Primary Outcome Measures:
  • Delay in development in end-stage renal failure in subjects with Advanced Diabetic Nephropathy (CKD stages 3 and 4) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: May 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Study Group: Active Comparator

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.
 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.
Control Group: No Intervention
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00708981

Contacts
Contact: Leon Fogelfeld, MD 312-864-0539 lfogelfe@cchil.org

Locations
United States, Illinois
John H. Stroger Jr. Hospital of Cook County Recruiting
Chicago, Illinois, United States, 60612
Principal Investigator: Leon Fogelfeld, MD            
Sponsors and Collaborators
John H. Stroger Hospital
Sanofi-Aventis
Investigators
Principal Investigator: Leon Fogelfeld, MD John H. Stroger, Jr. Hospital of Cook County, Endocrinology
  More Information

Responsible Party: John H. Stroger, Jr. Hospital of Cook County, Division of Endocrinology ( Leon Fogelfeld, MD )
Study ID Numbers: Metabolism IST, IRB# 06-177
Study First Received: June 26, 2008
Last Updated: July 1, 2008
ClinicalTrials.gov Identifier: NCT00708981  
Health Authority: United States: Institutional Review Board

Keywords provided by John H. Stroger Hospital:
Diabetic Nephropathy

Study placed in the following topic categories:
Insulin glulisine
Diabetic Nephropathies
Urologic Diseases
Glargine
Diabetes Mellitus
 Endocrine System Diseases
Endocrinopathy
Kidney Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on January 14, 2009



U.S. National Library of Medicine,  Contact Help Desk
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services