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

Primary Purpose

Diabetic Nephropathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multifactorial Intervention
Sponsored by
Cook County Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Nephropathy focused on measuring Diabetic Nephropathy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • John H. Stroger Jr. Hospital of Cook County

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Study Group

Control Group

Arm Description

Study group will receive multifactorial intervention for advanced diabetic nephropathy: Elements of multifactorial intervention: BP control of <130/80mmHg and renal protection with reduction of proteinuria to <0.5g/day using therapy with ACE inhibitors and/or ARBs. Tight glucose control with target of HbA1C of 7% and below using SMBG and Lantus/Apidra regimen. Use of hypolipidemic therapy to achieve targets of LDL < 70 mg/dl, HDL > 40/50 mg/dl (M/F)and TG < 200 mg/dl. Patient enhanced self-management provided by combined diabetes-renal education curriculum. Behavior and social intervention 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 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.

Outcomes

Primary Outcome Measures

Delay in development in end-stage renal failure in subjects with Advanced Diabetic Nephropathy (CKD stages 3 and 4)
Time to reaching End Stage Renal Disease (ESRD)

Secondary Outcome Measures

Full Information

First Posted
June 26, 2008
Last Updated
June 22, 2023
Sponsor
Cook County Health
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00708981
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cook County Health
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathy
Keywords
Diabetic Nephropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Active Comparator
Arm Description
Study group will receive multifactorial intervention for advanced diabetic nephropathy: Elements of multifactorial intervention: BP control of <130/80mmHg and renal protection with reduction of proteinuria to <0.5g/day using therapy with ACE inhibitors and/or ARBs. Tight glucose control with target of HbA1C of 7% and below using SMBG and Lantus/Apidra regimen. Use of hypolipidemic therapy to achieve targets of LDL < 70 mg/dl, HDL > 40/50 mg/dl (M/F)and TG < 200 mg/dl. Patient enhanced self-management provided by combined diabetes-renal education curriculum. Behavior and social intervention Intense case management that includes close follow-up of visits, laboratory monitoring and other self-adherence behaviors carried out by clinical research coordinators.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Multifactorial Intervention
Intervention Description
Study group will receive multifactorial intervention for advanced diabetic nephropathy: Elements of multifactorial intervention: BP control of <130/80mmHg and renal protection with reduction of proteinuria to <0.5g/day using therapy with ACE inhibitors and/or ARBs. Tight glucose control with target of HbA1C of 7% and below using SMBG and Lantus/Apidra regimen. Use of hypolipidemic therapy to achieve targets of LDL < 70 mg/dl, HDL > 40/50 mg/dl (M/F)and TG < 200 mg/dl. Patient enhanced self-management provided by combined diabetes-renal education curriculum. Behavior and social intervention Intense case management that includes close follow-up of visits, laboratory monitoring and other self-adherence behaviors carried out by clinical research coordinators.
Primary Outcome Measure Information:
Title
Delay in development in end-stage renal failure in subjects with Advanced Diabetic Nephropathy (CKD stages 3 and 4)
Description
Time to reaching End Stage Renal Disease (ESRD)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Minimal cognitive function for a diabetes self management Fasting or random Blood glucose <400mg/DL Exclusion Criteria: Patients with Type 1 Diabetes Mellitus. Serum Creatinine > 4.0 mg/dl and/or an estimated GFR of < 15 ml/min. Patients on renal replacement therapy. Patients with Hyperkalemia (K>5.0 meq/L). Patients with known Renal Artery stenosis. Patients with known cancer, hepatic impairment, dementia or other chronic medical diseases. Patients with severe heart failure (NYHA Class III or IV symptoms and/or LVEF <25%). Patients with valvular or outflow tract obstruction. Patients with significant disability that precludes regular attendance at clinics for follow-up. Patients unwilling or unable to provide informed consent. Pregnant or lactating women. Current addiction to substance or alcohol abuse.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leon Fogelfeld, MD
Organizational Affiliation
John H. Stroger, Jr. Hospital of Cook County, Endocrinology
Official's Role
Principal Investigator
Facility Information:
Facility Name
John H. Stroger Jr. Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

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

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