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

• ClinicalTrials.gov Identifier: NCT00708981
• Recruitment Status: Completed
• First Posted: July 3, 2008
• Last Update Posted: October 2, 2014
• Sponsor: John H. Stroger Hospital
• Collaborator: Sanofi
• Information provided by (Responsible Party): Leon Fogelfeld, John H. Stroger Hospital

Tracking Information

• First Submitted Date: June 26, 2008
• First Posted Date: July 3, 2008
• Last Update Posted Date: October 2, 2014
• Study Start Date: May 2007
• Actual Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 1, 2008): Delay in development in end-stage renal failure in subjects with Advanced Diabetic Nephropathy (CKD stages 3 and 4) [ Time Frame: 2 years ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Combined Diabetes-Renal Multifactorial Intervention In Patients With Advanced Diabetic Nephropathy (ADN)
• Official Title: Combined Diabetes-Renal Multifactorial Intervention In Patients With Advanced Diabetic Nephropathy (ADN)
• 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.

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 Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Diabetic Nephropathy

Intervention

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.

Study Arms

• 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.
  Intervention: Other: Multifactorial Intervention
• 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 11, 2011): 120
• Original Estimated Enrollment (submitted: July 1, 2008): 200
• Actual Study Completion Date: December 2013
• Actual Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00708981
• Other Study ID Numbers: Metabolism IST; IRB# 06-177
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Leon Fogelfeld, John H. Stroger Hospital
• Original Responsible Party: Leon Fogelfeld, MD, John H. Stroger, Jr. Hospital of Cook County, Division of Endocrinology
• Current Study Sponsor: John H. Stroger Hospital
• Original Study Sponsor: Same as current
• Collaborators: Sanofi

Investigators

• Principal Investigator: Leon Fogelfeld, MD; John H. Stroger, Jr. Hospital of Cook County, Endocrinology

• PRS Account: John H. Stroger Hospital
• Verification Date: September 2014