We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00708981
Recruitment Status : Completed
First Posted : July 3, 2008
Last Update Posted : October 2, 2014
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Leon Fogelfeld, John H. Stroger Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Diabetic Nephropathy Other: Multifactorial Intervention Phase 4

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Diabetes-Renal Multifactorial Intervention In Patients With Advanced Diabetic Nephropathy (ADN)
Study Start Date : May 2007
Actual Primary Completion Date : October 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Study Group

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.
No Intervention: Control Group
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Delay in development in end-stage renal failure in subjects with Advanced Diabetic Nephropathy (CKD stages 3 and 4) [ Time Frame: 2 years ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00708981


Locations
Layout table for location information
United States, Illinois
John H. Stroger Jr. Hospital of Cook County
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
John H. Stroger Hospital
Sanofi
Investigators
Layout table for investigator information
Principal Investigator: Leon Fogelfeld, MD John H. Stroger, Jr. Hospital of Cook County, Endocrinology
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Leon Fogelfeld, M.D., John H. Stroger Hospital
ClinicalTrials.gov Identifier: NCT00708981    
Other Study ID Numbers: Metabolism IST
IRB# 06-177
First Posted: July 3, 2008    Key Record Dates
Last Update Posted: October 2, 2014
Last Verified: September 2014
Keywords provided by Leon Fogelfeld, John H. Stroger Hospital:
Diabetic Nephropathy
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Male Urogenital Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases