Maria Luiza Caramori

Diabetic nephropathy is the leading cause of kidney disease in patients starting renal replacement therapy and affects approximately 40% of type 1 and type 2 diabetic patients. It increases the risk of death, mainly from cardiovascular causes, and is defined by increased urinary albumin excretion (UAE) in the absence of other renal diseases. Diabetic nephropathy is categorized into stages: microalbuminuria (UAE >20 microg/min and < or =199 microg/min) and macroalbuminuria (UAE > or =200 microg/min). Hyperglycemia, increased blood pressure levels, and genetic predisposition are the main risk factors for the development of diabetic nephropathy. Elevated serum lipids, smoking habits, and the amount and origin of dietary protein also seem to play a role as risk factors. Screening for microalbuminuria should be performed yearly, starting 5 years after diagnosis in type 1 diabetes or earlier in the presence of puberty or poor metabolic control. In patients with type 2 diabetes, screening should be performed at diagnosis and yearly thereafter. Patients with micro- and macroalbuminuria should undergo an evaluation regarding the presence of comorbid associations, especially retinopathy and macrovascular disease. Achieving the best metabolic control (A1c <7%), treating hypertension (<130/80 mmHg or <125/75 mmHg if proteinuria >1.0 g/24 h and increased serum creatinine), using drugs with blockade effect on the renin-angiotensin-aldosterone system, and treating dyslipidemia (LDL cholesterol <100 mg/dl) are effective strategies for preventing the development of microalbuminuria, in delaying the progression to more advanced stages of nephropathy and in reducing cardiovascular mortality in patients with type 1 and type 2 diabetes.

BACKGROUND: Higher serum urate levels are associated with an increased risk of diabetic kidney disease. Lowering of the serum urate level with allopurinol may slow the decrease in the glomerular filtration rate (GFR) in persons with type 1 diabetes and early-to-moderate diabetic kidney disease. METHODS: of body-surface area, and evidence of diabetic kidney disease to receive allopurinol or placebo. The primary outcome was the baseline-adjusted GFR, as measured with iohexol, after 3 years plus a 2-month washout period. Secondary outcomes included the decrease in the iohexol-based GFR per year and the urinary albumin excretion rate after washout. Safety was also assessed. RESULTS: per year; 95% CI, -1.5 to 0.4). The mean urinary albumin excretion rate after washout was 40% (95% CI, 0 to 80) higher with allopurinol than with placebo. The frequency of serious adverse events was similar in the two groups. CONCLUSIONS: We found no evidence of clinically meaningful benefits of serum urate reduction with allopurinol on kidney outcomes among patients with type 1 diabetes and early-to-moderate diabetic kidney disease. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; PERL ClinicalTrials.gov number, NCT02017171.).

Increased urinary albumin excretion rate is widely accepted as the first clinical sign of diabetic nephropathy. However, it is possible that some diabetic patients could first manifest reduced glomerular filtration rate (GFR) or hypertension. Relatively advanced diabetic renal lesions can be present in some diabetic patients with long-standing normoalbuminuria, and this might indicate increased risk of progression to microalbuminuria and then to overt diabetic nephropathy. The aim of this study was to identify a group of normoalbuminuric type 1 diabetic patients with low GFR and compare them with normoalbuminuric patients with normal GFR. Altogether, 105 normoalbuminuric type 1 diabetic patients with at least 10 years of diabetes duration that had a renal biopsy performed for research purposes were studied. Patients were divided according to GFR into groups with normal (>/=90 ml x min(-1) x 1.73 m(-2)) or reduced (<90 ml x min(-1) x 1.73 m(-2)) GFR. Clinical and renal structural parameters were compared between these two groups. Glomerular structural parameters were estimated by electron microscopic morphometry. The 23 patients with reduced GFR had more advanced diabetic glomerular lesions. The finding of reduced GFR was much more common among female patients, particularly if retinopathy and/or hypertension were also present. This report confirms that reduced GFR occurs among long-standing normoalbuminuric type 1 diabetic patients and is associated with more advanced diabetic glomerular lesions and, probably, with increased risk of progression. For these reasons, we suggest that regular measurements of GFR be performed in long-standing normoalbuminuric type 1 diabetic female diabetic patients, especially in those with retinopathy or hypertension.

The Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease represents the first KDIGO guideline on this subject. The guideline comes at a time when advances in diabetes technology and therapeutics offer new options to manage the large population of patients with diabetes and chronic kidney disease (CKD) at high risk of poor health outcomes. An enlarging base of high-quality evidence from randomized clinical trials is available to evaluate important new treatments offering organ protection, such as sodium-glucose cotransporter-2 inhibitors and glucagon-like peptide-1 receptor agonists. The goal of the new guideline is to provide evidence-based recommendations to optimize the clinical care of people with diabetes and CKD by integrating new options with existing management strategies. In addition, the guideline contains practice points to facilitate implementation when insufficient data are available to make well-justified recommendations or when additional guidance may be useful for clinical application. The guideline covers comprehensive care of patients with diabetes and CKD, glycemic monitoring and targets, lifestyle interventions, antihyperglycemic therapies, and self-management and health systems approaches to management of patients with diabetes and CKD. The Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease represents the first KDIGO guideline on this subject. The guideline comes at a time when advances in diabetes technology and therapeutics offer new options to manage the large population of patients with diabetes and chronic kidney disease (CKD) at high risk of poor health outcomes. An enlarging base of high-quality evidence from randomized clinical trials is available to evaluate important new treatments offering organ protection, such as sodium-glucose cotransporter-2 inhibitors and glucagon-like peptide-1 receptor agonists. The goal of the new guideline is to provide evidence-based recommendations to optimize the clinical care of people with diabetes and CKD by integrating new options with existing management strategies. In addition, the guideline contains practice points to facilitate implementation when insufficient data are available to make well-justified recommendations or when additional guidance may be useful for clinical application. The guideline covers comprehensive care of patients with diabetes and CKD, glycemic monitoring and targets, lifestyle interventions, antihyperglycemic therapies, and self-management and health systems approaches to management of patients with diabetes and CKD. This is the first Kidney Disease: Improving Global Outcomes (KDIGO) Guideline for Diabetes Management in Chronic Kidney Disease. The guideline comes at a pivotal time, with substantial growth in the public health burden of diabetes and chronic kidney disease (CKD), and with recent development of new therapies applicable to this population.1Afkarian M. Zelnick L.R. Hall Y.N. et al.Clinical manifestations of kidney disease among US adults with diabetes, 1988-2014.JAMA. 2016; 316: 602-610Crossref PubMed Scopus (505) Google Scholar,2Alicic R.Z. Rooney M.T. Tuttle K.R. Diabetic kidney disease: challenges, progress, and possibilities.Clin J Am Soc Nephrol. 2017; 12: 2032-2045Crossref PubMed Scopus (1020) Google Scholar The goal of the new guideline is to provide evidence-based recommendations and practice points to optimize the clinical care of people with diabetes and CKD by integrating new therapies with existing management approaches. The guideline was written by an international Work Group that included 2 patients and was diverse in clinical expertise, supported by a dedicated Evidence Review Team and professional KDIGO staff. The Work Group aimed to generate a useful resource for clinicians and patients that addressed relevant questions with actionable recommendations, took on controversial topics when there was sufficient evidence to do so, and communicated evidence and recommendations clearly. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework was used to evaluate the quality of evidence and strength of recommendations.3Guyatt G.H. Oxman A.D. Schunemann H.J. et al.GRADE guidelines: a new series of articles in the Journal of Clinical Epidemiology.J Clin Epidemiol. 2011; 64: 380-382Abstract Full Text Full Text PDF PubMed Scopus (1672) Google Scholar A broad audience was targeted, including all types of clinicians caring for people with diabetes and CKD. The scope of the new guideline includes patients with type 1 diabetes (T1D), type 2 diabetes (T2D), and all severities of CKD, including patients treated with dialysis or kidney transplantation. Where appropriate, differences in recommendations according to diabetes type or CKD severity are highlighted. The guideline focuses on interventions addressed with rigorous data (especially randomized clinical trials), including lifestyle, pharmacotherapy, and systems interventions. Topics with insufficient evidence evaluating clinical outcomes were not addressed. Readers are referred to related KDIGO guidelines for recommendations on treatment of blood pressure and lipids, and to guidelines from primary care and diabetes organizations for recommendations on prevention and screening of CKD in diabetes. The new guideline is organized into 5 chapters (Figure 1). Here in this summary, we outline by chapter the 12 evidence-based recommendations, including the general rationale for these recommendations, along with selected practice points. Practice points are opinion-based statements that lack sufficient evidence for a formal recommendation but were considered important by the Work Group to guide clinical care. Readers are referred to the full guideline for a comprehensive description of benefits and harms, level of evidence, factors affecting implementation, additional practice points, and recommendations for future research (https://www.kidney-international.org/issue/S0085-2538(20)X0010-X). In addition, the primary data and meta-analyses used to generate this guideline are available on the MAGICapp platform (https://kdigo.org/guidelines/diabetes-ckd/). Patients with diabetes and CKD have multisystem disease that requires treatment from a multidisciplinary team of health care professionals. These patients are at high risk of CKD progression and cardiovascular disease (CVD).4Fox C.S. Matsushita K. Woodward M. et al.Associations of kidney disease measures with mortality and end-stage renal disease in individuals with and without diabetes: a meta-analysis.Lancet. 2012; 380: 1662-1673Abstract Full Text Full Text PDF PubMed Scopus (737) Google Scholar,5Rawshani A. Rawshani A. Franzen S. et al.Risk factors, mortality, and cardiovascular outcomes in patients with type 2 diabetes.N Engl J Med. 2018; 379: 633-644Crossref PubMed Scopus (641) Google Scholar Comprehensive management includes a foundation of lifestyle intervention and risk factor management, with additional pharmacotherapy in selected patients (Figure 2).6Gaede P. Vedel P. Larsen N. et al.Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes.N Engl J Med. 2003; 348: 383-393Crossref PubMed Scopus (3812) Google Scholar Patients with T1D or T2D, hypertension, and albuminuria (persistent albumin-creatinine ratio ≥30 mg/g [3 mg/mmol]) should be treated with a renin–angiotensin system inhibitor (RASi). Multiple clinical trials in these populations demonstrate that RASi reduces risk of CKD progression in a manner that may be independent of blood pressure control.7Strippoli G.F. Bonifati C. Craig M. et al.Angiotensin converting enzyme inhibitors and angiotensin II receptor antagonists for preventing the progression of diabetic kidney disease.Cochrane Database Syst Rev. 2006; 4: CD006257PubMed Google Scholar RASi should be titrated to the maximum antihypertensive dose, as done in pivotal clinical trials, or the highest tolerated dose. Serum potassium and creatinine should be monitored. Measures to control potassium should be considered when serum potassium is elevated to continue RASi when possible. Patients with diabetes, hypertension, and normal albumin excretion are at lower risk of CKD progression. In this population, existing evidence does not demonstrate clear clinical benefits of RASi for CKD progression, and other agents are also appropriate for blood pressure management. There are few data evaluating clinical benefits and risks of RASi with diabetes and albuminuria who do not have hypertension. There are few data evaluating smoking cessation in patients with diabetes and CKD. Nonetheless, the potential harm of smoking is compelling, and all patients should be counseled to avoid tobacco products. Aspirin should generally be used lifelong for secondary prevention among those with established CVD and may be considered for primary prevention among high-risk individuals, with dual antiplatelet therapy used in patients after acute coronary syndrome or percutaneous coronary intervention. Hemoglobin A1c is the fundamental tool used for glycemic monitoring of patients with diabetes. This practice is supported by clinical trials demonstrating that targeting lower versus higher hemoglobin A1c values improves some clinically relevant outcomes, particularly microvascular damage.8de Boer I.H. DCCT/EDIC Research GroupKidney disease and related findings in the diabetes control and complications trial/epidemiology of diabetes interventions and complications study.Diabetes Care. 2014; 37: 24-30Crossref PubMed Scopus (162) Google Scholar,9Zoungas S. Arima H. Gerstein H.C. et al.Effects of intensive glucose control on microvascular outcomes in patients with type 2 diabetes: a meta-analysis of individual participant data from randomised controlled trials.Lancet Diabetes Endocrinol. 2017; 5: 431-437Abstract Full Text Full Text PDF PubMed Scopus (291) Google Scholar However, hemoglobin A1c is known to be inaccurate and imprecise in kidney failure.10Little R.R. Rohlfing C.L. Tennill A.L. et al.Measurement of Hba(1C) in patients with chronic renal failure.Clin Chim Acta. 2013; 418: 73-76Crossref PubMed Scopus (45) Google Scholar In particular, shortened red blood cell lifespan leads to a bias toward low hemoglobin A1c among patients treated with dialysis and erythropoietin-stimulating agents. Published studies suggest that the accuracy and precision of hemoglobin A1c, compared with direct measurements of blood glucose, do not vary by estimated glomerular filtration rate (eGFR) down to an eGFR of 30 ml/min per 1.73 m2.11Zelnick LR, Batacchi ZO, Ahmad I, et al. Continuous glucose monitoring and use of alternative markers to assess glycemia in chronic kidney disease [e-pub ahead of print]. Diabetes Care. doi: 10.2337/dc20-0915. Accessed September 2, 2020.Google Scholar Therefore, the Work Group recommended using hemoglobin A1c to monitor glycemic control in patients with diabetes and CKD, consistent with general diabetes care. At lower levels of eGFR and particularly with kidney failure, inaccuracy and imprecision of hemoglobin A1c may be increased. Hemoglobin A1c values should be interpreted with these limitations in mind. Continuous glucose monitoring (CGM) is a new technology that directly measures blood glucose and is not biased by CKD. CGM may be useful to index hemoglobin A1c values for patients in whom hemoglobin A1c is not concordant with directly measured blood glucose levels or clinical symptoms.11Zelnick LR, Batacchi ZO, Ahmad I, et al. Continuous glucose monitoring and use of alternative markers to assess glycemia in chronic kidney disease [e-pub ahead of print]. Diabetes Care. doi: 10.2337/dc20-0915. Accessed September 2, 2020.Google Scholar,12Bergenstal R.M. Beck R.W. Close K.L. et al.Glucose Management Indicator (GMI): a new term for estimating A1C from continuous glucose monitoring.Diabetes Care. 2018; 41: 2275-2280Crossref PubMed Scopus (278) Google Scholar In addition, CGM and self-monitoring of blood glucose can be used for short-term titration of treatments, prevention of hypoglycemia, and improvement of overall glycemic control.13Danne T. Nimri R. Battelino T. et al.International consensus on use of continuous glucose monitoring.Diabetes Care. 2017; 40: 1631-1640Crossref PubMed Scopus (1042) Google Scholar Monitoring of blood glucose is particularly relevant when the treatment includes antihyperglycemic therapies associated with risk of hypoglycemia, such as insulin or sulfonylureas. The guideline recommends that glycemic targets be individualized, consistent with recommendations from leading diabetes organizations worldwide.14American Diabetes Association6. Glycemic targets: standards of medical care in diabetes-2019.Diabetes Care. 2019; 42: S61-S70Crossref PubMed Scopus (487) Google Scholar For hemoglobin A1c, appropriate individualized targets may vary from as low as <6.5% to as high as <8%, depending on patient factors (Figure 3). Risk factors for hypoglycemia figure prominently in this scheme. Importantly, an enlarging menu of medications not associated with hypoglycemia is available for treatment of T2D, potentially allowing more aggressive glycemic targets for appropriate patients. In addition, CGM or self-monitoring of blood glucose may facilitate more aggressive targets while mitigating risk of hypoglycemia. For some patients, metrics derived from CGM (such as time in range, 70–180 mg/dl [3.9–10.0 mmol/l]) may serve as appropriate treatment targets, in addition to or instead of hemoglobin A1c.15Battelino T. Danne T. Bergenstal R.M. et al.Clinical targets for continuous glucose monitoring data interpretation: recommendations from the international consensus on time in range.Diabetes Care. 2019; 42: 1593-1603Crossref PubMed Scopus (1369) Google Scholar Patients with diabetes and CKD often receive a surfeit of advice to promote or restrict intake of certain foods or nutrients. This input may conflict with patients’ cultural or personal values and preferences, and it may lead to substantial confusion or exasperation. Adding to this, recommendations for intake in diabetes may contrast those for CKD. In this context, the Work Group felt it important that the overriding message of dietary advice be that patients should consume a balanced, healthy diet that is high in vegetables, fruits, whole grains, fiber, legumes, plant-based proteins, unsaturated fats, and nuts; and lower in processed meats, refined carbohydrates, and sweetened beverages. Dietary prescriptions should be individualized, incorporating values, preferences, and resources, and restricting certain foods or nutrients when appropriate (e.g., for treatment of hyperkalemia, when present). Decisions should be based on shared decision-making; include accredited nutrition providers, and diabetes health or other health who should be in the multidisciplinary care of the and cultural in resources, and when dietary options to the patients and The guideline recommends that dietary intake be at per the recommendation for the general and in Scholar Published trials do not provide evidence that restricting dietary intake to lower levels improves kidney or other clinical outcomes. For patients treated with particularly an in dietary intake to per is to and CKD often leads to blood and risks of CKD progression and cardiovascular There is some evidence, from populations diabetes and CKD, that the of dietary reduces these outcomes. Therefore, the Work Group that intake be to consistent with the KDIGO guideline on blood pressure management and international guidelines on the prevention and treatment of for and Scholar Patients with diabetes and CKD have lower levels of along with overall levels as compared with the general S. et and mortality in the general population and CKD J Am Soc Nephrol. PubMed Scopus Google Scholar but few clinical trials have the of and implementation of in this In the general population and in those with diabetes, improvement in levels and A. guideline on the primary prevention of cardiovascular disease: lifestyle and 2019; 4: PubMed Scopus Google Scholar for a of at per is recommended and should be is often to the advice for implementation to be For patients, may glycemic blood other and clinical outcomes. However, evidence not data demonstrating clinical benefits of interventions among people with diabetes and CKD, and interventions targeting intake may harm by particularly in CKD. Therefore, interventions were as an for additional research is and recommendations for clinical care were not antihyperglycemic have and for clinical including cotransporter-2 inhibitors glucagon-like peptide-1 receptor and inhibitors R.Z. Rooney M.T. Tuttle K.R. Diabetic kidney disease: challenges, progress, and possibilities.Clin J Am Soc Nephrol. 2017; 12: 2032-2045Crossref PubMed Scopus (1020) Google Scholar these new have in large clinical trials of people with that clinically important cardiovascular and kidney outcomes (Figure These trials provide substantial evidence to by a rigorous of the Work Group these data to of therapy for patients with and CKD. evaluating new and treatments are for patients with T1D and CKD, for whom therapy focuses on Therefore, antihyperglycemic management in T1D was to existing diabetes The guideline recommends that glycemic management for patients with and CKD should include lifestyle treatment with and an and additional therapy as for glycemic control (Figure The Work Group that patients with diabetes, CKD, and eGFR ≥30 ml/min per 1.73 from treatment with an and generally that blood glucose, and an to offer substantial benefits in risks of CKD and these are not available or not or when are insufficient to individualized glycemic additional should be selected based on patient preferences, and (Figure In are additional agents of to cardiovascular particularly among people with and also potential to of albuminuria known as and in factors the of other cotransporter-2 inhibitors and in type 2 diabetes and chronic kidney cardiovascular estimated glomerular filtration glucagon-like peptide-1 receptor to be in hemoglobin A1c in patients with T2D, with low risks for hypoglycemia in the general population and patients with CKD. 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P. et term treatment with in patients with type 2 diabetes and risk of randomised controlled PubMed Scopus Google Scholar were in patients with in cardiovascular outcomes trials trials, and and 1 dedicated kidney outcomes in a CKD population et and cardiovascular and renal in type 2 diabetes.N Engl J Med. 2017; PubMed Scopus Google et and renal outcomes in type 2 diabetes and Engl J Med. 2019; 380: PubMed Scopus Google et and cardiovascular outcomes in type 2 diabetes.N Engl J Med. 2019; 380: PubMed Scopus Google C. et cardiovascular outcomes, and mortality in type 2 diabetes.N Engl J Med. PubMed Scopus Google Scholar These trials large for of cardiovascular ratio for cardiovascular and CKD progression At the time of this from a of among patients with CKD were at the of a substantial risk in the primary in kidney failure, or renal or cardiovascular compared to were by diabetes and levels of eGFR and is consistent with trials among patients with diabetes. 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