title: Combined diabetes-renal multifactorial intervention in patients with advanced diabetic nephropathy: Proof-of-concept.
abstract: OBJECTIVE
  To evaluate efficacy of a multifactorial-multidisciplinary approach in delaying CKD 3-4 progression to ESRD.
  
  
  METHODS
  Two-year proof-of-concept stratified randomized control trial conducted in an outpatient clinic of a large public hospital system. This intervention, led by a team of endocrinologists, nephrologists, nurse practitioners, and registered dietitians, integrated intensive diabetes-renal care with behavioral/dietary and pharmacological interventions. 120 low-income adults with T2DM and CKD 3-4 enrolled; 58% male, 55% African American, 23% Hispanic.
  
  
  RESULTS
  Primary outcome was progression rate from CKD 3-4 to ESRD. Fewer intervention (13%) than control (28%) developed ESRD, p<0.05. Intervention had greater albumin/creatinine ratio (ACR) decrease (62% vs. 42%, p<0.05) and A1C<7% attainment (50% vs. 30%, p<0.05) and trended toward better lipid/blood pressure control (p=NS). Significant differences between 25 ESRD and 95 ESRD-free patients were baseline eGFR (28 vs. 40ml/min/1.73m2), annual eGFR decline (15 vs. 3ml/min/year), baseline ACR (2362 vs. 1139mg/g), final ACR (2896 vs. 1201mg/g), and final A1C (6.9 vs. 7.8%). In multivariate Cox analysis, receiving the intervention reduced hazard ratio to develop ESRD (0.125, CI 0.029-0.54) as did higher baseline eGFR (0.69, CI 0.59-0.80). Greater annual eGFR decline increased hazard ratio (1.59, CI 1.34-1.87).
  
  
  CONCLUSIONS
  The intervention delayed ESRD. Improved A1C and ACR plus not-yet-identified variables may have influenced better outcomes. Multifactorial-multidisciplinary care may serve as a CKD 3-4 treatment paradigm.
authors.affiliation: Division of Endocrinology, Cook County Health & Hospitals System, Chicago, IL. Electronic address: lfogelfeld@cookcountyhhs.org.
authors.forename: Leon
authors.initials: L
authors.lastname: Fogelfeld
authors.affiliation: Division of Nephrology, Cook County Health & Hospitals System, Chicago, IL.
authors.forename: Peter
authors.initials: P
authors.lastname: Hart
authors.affiliation: Division of Endocrinology, Cook County Health & Hospitals System, Chicago, IL.
authors.forename: Jadwiga
authors.initials: J
authors.lastname: Miernik
authors.affiliation: Division of Nephrology, Cook County Health & Hospitals System, Chicago, IL.
authors.forename: Jocelyn
authors.initials: J
authors.lastname: Ko
authors.affiliation: Department of Nursing, University of Illinois at Chicago, Chicago, IL.
authors.forename: Donna
authors.initials: D
authors.lastname: Calvin
authors.affiliation: Division of Endocrinology, Cook County Health & Hospitals System, Chicago, IL.
authors.forename: Bettina
authors.initials: B
authors.lastname: Tahsin
authors.affiliation: Division of Endocrinology, Cook County Health & Hospitals System, Chicago, IL.
authors.forename: Anwar
authors.initials: A
authors.lastname: Adhami
authors.affiliation: Division of Endocrinology, Cook County Health & Hospitals System, Chicago, IL.
authors.forename: Rajeev
authors.initials: R
authors.lastname: Mehrotra
authors.affiliation: Department of Nursing, Rush University Medical Center, Chicago, IL.
authors.forename: Louis
authors.initials: L
authors.lastname: Fogg
mesh_terms: D002641:Chicago / Q000453:epidemiology; D003131:Combined Modality Therapy; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000628:therapy*; D003928:Diabetic Nephropathies / Q000503:physiopathology / Q000628:therapy*; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D005919:Glomerular Filtration Rate; D006779:Hospitals, Public; D006801:Humans; D015994:Incidence; D007668:Kidney / Q000503:physiopathology*; D007676:Kidney Failure, Chronic / Q000150:complications / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D010044:Outpatient Clinics, Hospital; D010348:Patient Care Team; D010352:Patient Dropouts; D011203:Poverty; D000075082:Proof of Concept Study; D016016:Proportional Hazards Models; D051436:Renal Insufficiency, Chronic / Q000150:complications / Q000503:physiopathology / Q000628:therapy*; D012307:Risk Factors; D012720:Severity of Illness Index
keywords: Advanced diabetic nephropathy; Chronic disease management; Delaying ESRD; Diabetes comorbidities; Multidisciplinary-multifactorial care