Combined Diabetes-Renal Multifactorial Intervention in Patients with Advanced Diabetic Nephropathy: Proof-of-Concept

• Published in: Journal of diabetes and its complications 2017-03, Vol.31 (3), p.624-630
• Main Authors: Fogelfeld, Leon, Hart, Peter, Miernik, Jadwiga, Ko, Jocelyn, Calvin, Donna, Tahsin, Bettina, Adhami, Anwar, Mehrotra, Rajeev, Fogg, Louis
• Format: Article
• Language: English
• Subjects: Advanced diabetic nephropathy; Chicago - epidemiology; Chronic disease management; Combined Modality Therapy; Delaying ESRD; Diabetes; Diabetes comorbidities; Diabetes Mellitus, Type 2 - complications; Diabetes Mellitus, Type 2 - therapy; Diabetic Nephropathies - physiopathology; Diabetic Nephropathies - therapy; Disease Progression; Disease-Free Survival; Drug therapy; Endocrinology & Metabolism; Female; Glomerular Filtration Rate; Hospitals, Public; Humans; Hypertension; Hypoglycemia; Incidence; Insulin; Intervention; Kidney - physiopathology; Kidney diseases; Kidney Failure, Chronic - complications; Kidney Failure, Chronic - epidemiology; Kidney Failure, Chronic - etiology; Kidney Failure, Chronic - prevention & control; Lipids; Male; Middle Aged; Multidisciplinary-multifactorial care; Outpatient Clinics, Hospital; Patient Care Team; Patient Dropouts; Patients; Poverty; Proof of Concept Study; Proportional Hazards Models; Renal Insufficiency, Chronic - complications; Renal Insufficiency, Chronic - physiopathology; Renal Insufficiency, Chronic - therapy; Risk Factors; Severity of Illness Index; Triglycerides
• ISSN: 1056-8727; 1873-460X
• DOI: 10.1016/j.jdiacomp.2016.11.019

Abstract Aims To evaluate efficacy of a multifactorial-multidisciplinary approach in delaying CKD 3–4 progression to ESRD. Methods 2-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), A1C < 7% attainment (50% vs. 30%, p < 0.05) and trended towards better lipid/blood pressure control (p = NS). Significant differences between 25 ESRD and 95 ESRD-free patients were baseline eGFR (28 vs. 40 ml/min/1.73m2 ), annual eGFR decline (15 vs. 3 ml/min/year), baseline ACR (2362 vs. 1139 mg/g), final ACR (2896 vs. 1201 mg/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.