Clinical trial NCT00708981: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Nephropathy
Keywords: Diabetic Nephropathy
Lead sponsor: Cook County Health
Sponsor class: OTHER_GOV
Collaborators: name: Sanofi
First posted: 2008-07-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Delay in development in end-stage renal failure in subjects with Advanced Diabetic Nephropathy (CKD stages 3 and 4)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: John H. Stroger Jr. Hospital of Cook County
state: Illinois
Study officials:
affiliation: John H. Stroger, Jr. Hospital of Cook County, Endocrinology
name: Leon Fogelfeld, MD
role: PRINCIPAL_INVESTIGATOR
References: