Combined Diabetes-Renal Multifactorial Intervention in Patients with Advanced Diabetic Nephropathy: Proof-of-Concept
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 endo...
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| Veröffentlicht in: | Journal of diabetes and its complications 2017-03, Vol.31 (3), p.624-630 |
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| creator | Fogelfeld, Leon Hart, Peter Miernik, Jadwiga Ko, Jocelyn Calvin, Donna Tahsin, Bettina Adhami, Anwar Mehrotra, Rajeev Fogg, Louis |
| description | 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. |
| doi_str_mv | 10.1016/j.jdiacomp.2016.11.019 |
| format | Article |
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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.</description><identifier>ISSN: 1056-8727</identifier><identifier>EISSN: 1873-460X</identifier><identifier>DOI: 10.1016/j.jdiacomp.2016.11.019</identifier><identifier>PMID: 28041817</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>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</subject><ispartof>Journal of diabetes and its complications, 2017-03, Vol.31 (3), p.624-630</ispartof><rights>2017 Elsevier Inc.</rights><rights>Copyright © 2017 Elsevier Inc. All rights reserved.</rights><rights>Copyright Elsevier Limited Mar 01, 2017</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c451t-c7acc91372124e952db43ae9a99ecd02ab390296224be48ee7596670d5d8e3ff3</citedby><cites>FETCH-LOGICAL-c451t-c7acc91372124e952db43ae9a99ecd02ab390296224be48ee7596670d5d8e3ff3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1056872716309783$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28041817$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Fogelfeld, Leon</creatorcontrib><creatorcontrib>Hart, Peter</creatorcontrib><creatorcontrib>Miernik, Jadwiga</creatorcontrib><creatorcontrib>Ko, Jocelyn</creatorcontrib><creatorcontrib>Calvin, Donna</creatorcontrib><creatorcontrib>Tahsin, Bettina</creatorcontrib><creatorcontrib>Adhami, Anwar</creatorcontrib><creatorcontrib>Mehrotra, Rajeev</creatorcontrib><creatorcontrib>Fogg, Louis</creatorcontrib><title>Combined Diabetes-Renal Multifactorial Intervention in Patients with Advanced Diabetic Nephropathy: Proof-of-Concept</title><title>Journal of diabetes and its complications</title><addtitle>J Diabetes Complications</addtitle><description>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.</description><subject>Advanced diabetic nephropathy</subject><subject>Chicago - epidemiology</subject><subject>Chronic disease management</subject><subject>Combined Modality Therapy</subject><subject>Delaying ESRD</subject><subject>Diabetes</subject><subject>Diabetes comorbidities</subject><subject>Diabetes Mellitus, Type 2 - complications</subject><subject>Diabetes Mellitus, Type 2 - therapy</subject><subject>Diabetic Nephropathies - physiopathology</subject><subject>Diabetic Nephropathies - therapy</subject><subject>Disease Progression</subject><subject>Disease-Free Survival</subject><subject>Drug therapy</subject><subject>Endocrinology & Metabolism</subject><subject>Female</subject><subject>Glomerular Filtration Rate</subject><subject>Hospitals, Public</subject><subject>Humans</subject><subject>Hypertension</subject><subject>Hypoglycemia</subject><subject>Incidence</subject><subject>Insulin</subject><subject>Intervention</subject><subject>Kidney - physiopathology</subject><subject>Kidney diseases</subject><subject>Kidney Failure, Chronic - complications</subject><subject>Kidney Failure, Chronic - epidemiology</subject><subject>Kidney Failure, Chronic - etiology</subject><subject>Kidney Failure, Chronic - prevention & control</subject><subject>Lipids</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Multidisciplinary-multifactorial care</subject><subject>Outpatient Clinics, Hospital</subject><subject>Patient Care Team</subject><subject>Patient Dropouts</subject><subject>Patients</subject><subject>Poverty</subject><subject>Proof of Concept Study</subject><subject>Proportional Hazards Models</subject><subject>Renal Insufficiency, Chronic - complications</subject><subject>Renal Insufficiency, Chronic - physiopathology</subject><subject>Renal Insufficiency, Chronic - therapy</subject><subject>Risk Factors</subject><subject>Severity of Illness Index</subject><subject>Triglycerides</subject><issn>1056-8727</issn><issn>1873-460X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFkluL1TAUhYsozs2_MBR88aU1lzYXH8ThOOrAqMOo4FtI011OatvUJD1y_r0pZ2aEeRECyYZvr03W2ll2jlGJEWav-7JvrTZunEuS6hLjEmH5JDvGgtOiYujn0_RGNSsEJ_woOwmhRwixusbPsyMiUIUF5sdZ3LixsRO0-XurG4gQiluY9JB_XoZoO22i8zaVV1MEv4MpWjfldspvdLSpCvkfG7f5RbvTk3kQsSb_AvPWu1nH7f5NfuOd64p0Ni5RczzLnnV6CPDi7j7Nfny4_L75VFx__Xi1ubguTFXjWBiujZGYcoJJBbImbVNRDVJLCaZFRDdUIiIZIVUDlQDgtWSMo7ZuBdCuo6fZq4Pu7N3vBUJUow0GhkFP4JagsKgrgShHPKEvH6G9W3wyYqU4qRllgiWKHSjjXQgeOjV7O2q_VxipNRfVq_tc1JqLwlilXFLj-Z380ozQPrTdB5GAdwcAkh87C14FkwxOnloPJqrW2f_PePtIwgx2skYPv2AP4d9_VCAKqW_rdqzLgRlFkgtK_wLy8rei</recordid><startdate>20170301</startdate><enddate>20170301</enddate><creator>Fogelfeld, Leon</creator><creator>Hart, Peter</creator><creator>Miernik, Jadwiga</creator><creator>Ko, Jocelyn</creator><creator>Calvin, Donna</creator><creator>Tahsin, Bettina</creator><creator>Adhami, Anwar</creator><creator>Mehrotra, Rajeev</creator><creator>Fogg, Louis</creator><general>Elsevier Inc</general><general>Elsevier Limited</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>ASE</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FPQ</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>K6X</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>M2O</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20170301</creationdate><title>Combined Diabetes-Renal Multifactorial Intervention in Patients with Advanced Diabetic Nephropathy: Proof-of-Concept</title><author>Fogelfeld, Leon ; Hart, Peter ; Miernik, Jadwiga ; Ko, Jocelyn ; Calvin, Donna ; Tahsin, Bettina ; Adhami, Anwar ; Mehrotra, Rajeev ; Fogg, Louis</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c451t-c7acc91372124e952db43ae9a99ecd02ab390296224be48ee7596670d5d8e3ff3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Advanced diabetic nephropathy</topic><topic>Chicago - epidemiology</topic><topic>Chronic disease management</topic><topic>Combined Modality Therapy</topic><topic>Delaying ESRD</topic><topic>Diabetes</topic><topic>Diabetes comorbidities</topic><topic>Diabetes Mellitus, Type 2 - complications</topic><topic>Diabetes Mellitus, Type 2 - therapy</topic><topic>Diabetic Nephropathies - physiopathology</topic><topic>Diabetic Nephropathies - therapy</topic><topic>Disease Progression</topic><topic>Disease-Free Survival</topic><topic>Drug therapy</topic><topic>Endocrinology & Metabolism</topic><topic>Female</topic><topic>Glomerular Filtration Rate</topic><topic>Hospitals, Public</topic><topic>Humans</topic><topic>Hypertension</topic><topic>Hypoglycemia</topic><topic>Incidence</topic><topic>Insulin</topic><topic>Intervention</topic><topic>Kidney - physiopathology</topic><topic>Kidney diseases</topic><topic>Kidney Failure, Chronic - complications</topic><topic>Kidney Failure, Chronic - epidemiology</topic><topic>Kidney Failure, Chronic - etiology</topic><topic>Kidney Failure, Chronic - prevention & control</topic><topic>Lipids</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Multidisciplinary-multifactorial care</topic><topic>Outpatient Clinics, Hospital</topic><topic>Patient Care Team</topic><topic>Patient Dropouts</topic><topic>Patients</topic><topic>Poverty</topic><topic>Proof of Concept Study</topic><topic>Proportional Hazards Models</topic><topic>Renal Insufficiency, Chronic - complications</topic><topic>Renal Insufficiency, Chronic - physiopathology</topic><topic>Renal Insufficiency, Chronic - therapy</topic><topic>Risk Factors</topic><topic>Severity of Illness Index</topic><topic>Triglycerides</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Fogelfeld, Leon</creatorcontrib><creatorcontrib>Hart, Peter</creatorcontrib><creatorcontrib>Miernik, Jadwiga</creatorcontrib><creatorcontrib>Ko, Jocelyn</creatorcontrib><creatorcontrib>Calvin, Donna</creatorcontrib><creatorcontrib>Tahsin, Bettina</creatorcontrib><creatorcontrib>Adhami, Anwar</creatorcontrib><creatorcontrib>Mehrotra, Rajeev</creatorcontrib><creatorcontrib>Fogg, Louis</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>British Nursing Database</collection><collection>British Nursing Index</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>British Nursing Index (BNI) (1985 to Present)</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>British Nursing Index</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of diabetes and its complications</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Fogelfeld, Leon</au><au>Hart, Peter</au><au>Miernik, Jadwiga</au><au>Ko, Jocelyn</au><au>Calvin, Donna</au><au>Tahsin, Bettina</au><au>Adhami, Anwar</au><au>Mehrotra, Rajeev</au><au>Fogg, Louis</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Combined Diabetes-Renal Multifactorial Intervention in Patients with Advanced Diabetic Nephropathy: Proof-of-Concept</atitle><jtitle>Journal of diabetes and its complications</jtitle><addtitle>J Diabetes Complications</addtitle><date>2017-03-01</date><risdate>2017</risdate><volume>31</volume><issue>3</issue><spage>624</spage><epage>630</epage><pages>624-630</pages><issn>1056-8727</issn><eissn>1873-460X</eissn><abstract>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.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>28041817</pmid><doi>10.1016/j.jdiacomp.2016.11.019</doi><tpages>7</tpages></addata></record> |
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| 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 |
| title | Combined Diabetes-Renal Multifactorial Intervention in Patients with Advanced Diabetic Nephropathy: Proof-of-Concept |
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