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

NCT00708981 | Completed DMC

• 2 other identifiers: 06-177 Metabolism ISTIRB 06-177
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Nephropathy

Keywords

Diabetic Nephropathy

Outcome Measures

Primary Outcomes (1)

• 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)

  2 years

Study Arms (2)

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

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.

Interventions

Multifactorial Intervention OTHER

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 Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cook County Health: lead
• Sanofi: collaborator

Study Sites (1)

John H. Stroger Jr. Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• Cashmore BA, Cooper TE, Evangelidis NM, Green SC, Lopez-Vargas P, Tunnicliffe DJ. Education programmes for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 Aug 22;8(8):CD007374. doi: 10.1002/14651858.CD007374.pub3.

  PMID: 39171639 DERIVED

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Leon Fogelfeld, MD

  John H. Stroger, Jr. Hospital of Cook County, Endocrinology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: June 26, 2008
• First Posted: July 3, 2008
• Study Start: May 1, 2007
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 26, 2024

Record last verified: 2024-08

Locations

US (1)