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BACKGROUND: The current diagnostic criteria for amyotrophic lateral sclerosis (ALS) may remain unsatisfactory for months or years in the early disease. Pulmonary assessment has never been considered useful in the early diagnosis of ALS, and studies of pulmonary function in this patient category are lacking. OBJECTIVES: The objective of this study was to assess the pulmonary function in subjects with unspecific symptoms of ALS in whom an ALS diagnosis cannot be reached based on the current available guidelines. METHODS: We performed pulmonary function tests, arterial gas analysis, maximal inspiratory (MIP) and expiratory (MEP) pressure, and respiratory drive (P0.1) assessment in 35 patients with unspecific neurological symptoms at the time of the visit and those were subsequently diagnosed with ALS 2 years after the initial visit ("pre-ALS"); we compared these patients with 29 patients with established ALS and with 28 control subjects. RESULTS: Spirometric parameters were not different between the three groups. However, MIP was significantly lower and P0.1 was significantly increased (with the ratio P0.1/MIP significantly higher) in both established and pre-ALS patients compared to controls, while both MIP and P0.1 were similar between established ALS and pre-ALS. CONCLUSIONS: Changes in MIP, P0.1, and P0.1/MIP ratio are highly suggestive of preclinical ALS when the spirometry and neurodiagnostic tests are still inconclusive. MIP and P0.1 are noninvasive measurements that can be easily assessed in an ambulatory setting. Future studies on larger cohorts are needed to validate the use of these parameters in the preclinical diagnosis of ALS as well as in other neuromuscular diseases.
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Esclerosis Amiotrófica Lateral , Humanos , Esclerosis Amiotrófica Lateral/diagnóstico , Respiración , Pruebas de Función Respiratoria , Pulmón , EspiraciónRESUMEN
Background and Objectives: Diabetes mellitus (DM) and hypertension (HT) are characterized by cell damage caused by inflammatory and metabolic mechanisms induced by alteration in reduction-oxidative status. Serum advanced oxidation protein products (AOPP) are new markers of protein damage induced by oxidative stress. We evaluated serum levels of AOPP in a cohort of patients with DM and HT, with or without renal complications, compared with a control healthy population. Materials and Methods: The study group comprised of 62 patients with type 2 DM and 56 with HT. The 62 patients affected by DM were further distinguished in 24 subjects without renal impairment, 18 with diabetic nephropathy (DN), 20 with chronic kidney disease (CKD) stage 2-3 secondary to DN. The subgroup of 56 patients with primary HT comprised 26 subjects without renal complications and 30 with CKD (stage 2-3) secondary to HT. Thirty healthy controls, matched for age and sex, were recruited among blood donors. Results: Increased AOPP levels were found in DM patients compared with healthy subjects, although not significantly. This index was higher and more significant in patients with DN and CKD secondary to DN than in DM patients without nephropathy (p < 0.05) or controls (p < 0.0001). Patients with HT and with kidney impairment secondary to HT also had significantly higher AOPP serum levels than controls (p < 0.01 and p < 0.0001, respectively). There were no significant differences in mean AOPP levels among DM and HT patients. Conclusion: Our study showed that oxidative stress was higher in diabetic or hypertensive subjects than in healthy controls and, in particular, it appeared to be more severe in patients with renal complications. We suggest that the assessment of AOPP in diabetic and hypertensive patients may be important to predict the onset of renal failure and to open a new perspective on the adoption of antioxidant molecules to prevent CKD in those settings.
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Productos Avanzados de Oxidación de Proteínas/análisis , Nefropatías Diabéticas/clasificación , Hipertensión Renal/clasificación , Nefritis/clasificación , Adulto , Productos Avanzados de Oxidación de Proteínas/sangre , Anciano , Estudios de Cohortes , Diabetes Mellitus Tipo 2/sangre , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/fisiopatología , Nefropatías Diabéticas/sangre , Nefropatías Diabéticas/fisiopatología , Femenino , Humanos , Hipertensión Renal/sangre , Hipertensión Renal/fisiopatología , Italia , Masculino , Persona de Mediana Edad , Nefritis/sangre , Nefritis/fisiopatología , Estrés OxidativoRESUMEN
Tirzepatide is the first ever once-weekly, injectable gastric inhibitory peptide/glucagon-like peptide 1 (GIP/GLP-1) dual agonist approved by the European Medicines Agency for type 2 diabetes. The efficacy and safety of tirzepatide have been evaluated in five global, randomized, double-blind or open-label, phase 3 studies which enrolled over 7000 people living with type 2 diabetes, across various stages of disease and with different characteristics at baseline. In this short commentary we report the salient data of the most recent trials on tirzepatide and GLP-1 receptor agonists from a clinical point of view, with the aim of highlighting similarities and mutual differences.
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Pain is a major health problem in end-stage renal disease (ESRD) affecting half of the dialysis patients; most of them experience a moderate to severe degree of pain. Nevertheless, the impact of chronic pain and its consequences are often underestimated. Sources of pain related to the uremic environment are renal bone disease (osteitis fibrosa cystica, amyloidosis, osteomalacia), osteoarthritis, calcific uremic arteriolopathy and peripheral neuropathy. Moreover, comorbid conditions such as ischemic peripheral artery disease, diabetic neuropathy, osteopenia/ osteoporosis (due to long-standing hypertension, diabetes, or old age) result in various kinds of pain. Also the primary kidney disease (e.g. autosomal dominant polycystic kidney disease (ADPKD)) as well as performance of hemodialysis or peritoneal dialysis are important causes of pain. Potential consequences of persistent pain are disturbed sleep, weakened memory/attention, altered mood (anxiety and depressive disorder), impotence, poorer physical state, less social activities and consideration of withdrawal from dialysis. Consequently the health-related-quality of life (HRQOL) is diminished, associated with a higher morbidity and mortality. In the therapy of pain the WHO three-step analgesic ladder adapted for ESRD, was shown to be effective in dialysis patients. Of fundamental importance are various forms of non-pharmacological strategies including electrotherapy. Recently the so-called high tone external muscle stimulation (HTEMS) was very effective in the management of neuropathic pain in ESRD patients.
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Terapia por Estimulación Eléctrica/métodos , Fallo Renal Crónico/complicaciones , Enfermedades del Sistema Nervioso Periférico/etiología , Enfermedades del Sistema Nervioso Periférico/terapia , Comorbilidad , Humanos , Fallo Renal Crónico/mortalidad , Neuralgia/etiología , Neuralgia/mortalidad , Neuralgia/terapia , Enfermedades del Sistema Nervioso Periférico/mortalidadRESUMEN
BACKGROUND: In chronic hemodialysis patients with secondary hyperparathyroidism, pathological modifications of bone and mineral metabolism increase the risk of cardiovascular morbidity and mortality. Parathyroidectomy, reducing the incidence of cardiovascular events, may improve outcomes; however, its effects on long-term survival are still subject of active research. METHODS: From January 2004 to December 2006, 30 hemodialysis patients, affected by severe and unresponsive secondary hyperparathyroidism, underwent parathyroidectomy - 15 total parathyroidectomy and 15 total parathyroidectomy + subcutaneous autoimplantation. During a 5-year follow-up, patients did not receive a renal transplantation and were evaluated for biochemical modifications and major cardiovascular events - death, cardiovascular accidents, myocardial infarction and peripheral vascular disease. Results were compared with those obtained in a control group of 20 hemodialysis patients, affected by secondary hyperparathyroidism, and refusing surgical treatment, and following medical treatment only. RESULTS: The groups were comparable in terms of age, gender, dialysis vintage, and comorbidities. Postoperative cardiovascular events were observed in 18/30 - 54% - surgical patients and in 4/20 - 20%- medical patients, with a mortality rate respectively of 23.3% in the surgical group vs. 15% in the control group. Parathyroidectomy was not associated with a reduced risk of cardiovascular morbidity and survival rate was unaffected by surgical treatment. CONCLUSIONS: In secondary hyperparathyroidism hemodialysis patients affected by severe cardiovascular disease, surgery did not modify cardiovascular morbidity and mortality rates. Therefore, in secondary hyperparathyroidism hemodialysis patients, resistant to medical treatment, only an early indication to calcimimetics, or surgery, in the initial stage of chronic kidney disease - mineral bone disorders, may offer a higher long-term survival. Further studies will be useful to clarify the role of secondary hyperparathyroidism in determining unfavorable cardiovascular outcomes and mortality in hemodialysis population.
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Enfermedades Cardiovasculares/prevención & control , Hiperparatiroidismo Secundario/cirugía , Paratiroidectomía , Diálisis Renal , Calcimiméticos/uso terapéutico , Enfermedades Cardiovasculares/etiología , Enfermedades Cardiovasculares/mortalidad , Femenino , Humanos , Hiperparatiroidismo Secundario/complicaciones , Hiperparatiroidismo Secundario/tratamiento farmacológico , Hiperparatiroidismo Secundario/mortalidad , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Tasa de Supervivencia , Resultado del TratamientoRESUMEN
INTRODUCTION: Non-alcoholic fatty liver disease (NAFLD) is part of a disease spectrum ranging from steatosis to steatohepatitis (NASH), fibrosis, and cirrhosis, and when associated with metabolic syndrome (MS), and overt diabetes is defined as metabolic NAFLD (MAFLD). Some easily available, inexpensive biomarkers have been validated based on common anthropometric and laboratory parameters, including the Fatty Liver Index (FLI), the Fibrosis (FIB)-4 Score (FIB-4), and the NAFLD Fibrosis Score (NFS). In people with overweight/obesity, MS, and diabetes, the pathogenesis of fatty liver involves parameters known to be positively affected by Policaptil Gel Retard (PGR), a phytocomplex already successfully used in adolescents and adults with MS and type 2 diabetes mellitus (T2DM). This study's primary outcome was to assess PGR's ability to improve indirect validated signs of liver steatosis and fibrosis, i.e., FLI, FIB-4, and NFS Scores; as the secondary outcome, we aimed to confirm PGR's positive effects on anthropometric parameters and lipid levels and to assess any eventually occurring cytolysis liver marker changes in patients with MS/T2DM and MAFLD/NASH. METHODS: In this spontaneous, longitudinal, single-blind, randomized clinical study, 245 outpatients with MS/T2DM were enrolled and randomized to PGR or placebo for 24 weeks. All underwent a low-calorie diet (20-25% less than the calories required to maintain current weight) and were encouraged to intensify physical activity. Fat distribution, liver fat content/fibrosis, and biochemical parameters were evaluated at baseline and after 24 weeks. RESULTS: Our data show for the first time in adults with MAFLD that, when added to lifestyle changes including a hypocaloric diet and intensified physical activity, PGR improves lipid and glucose metabolism-related parameters, including insulin-resistance, and significantly reduces not only visceral fat but also liver fat content and related liver fibrosis severity. The prevalence of subjects with severe steatosis (FLI > 60) significantly decreased from 95.08 to 47.53% (p < 0.001) only in the treatment group, which also displayed a significantly decreased prevalence of medium-severe cases (F3-F4) from 83.62% to 52.35% (p < 0.001) and a markedly increased prevalence of low degree cases (F0-F1) from 9.01 to 42.15% (p < 0.001). CONCLUSIONS: The effect of PGR is related to a reduction in the post-meal blood glucose and insulin peaks. As glucose absorption (GA) directly regulates pancreatic insulin release, the attenuated insulin response is likely due to delayed GA with decreased body weight, visceral fat, and cardiovascular risk. Also, an effect on the intestinal microbiota, already documented in the animal model, cannot be excluded, especially considering the reported PGR-related shift from the Firmicutes, notoriously responsible for increased lipid gut absorption, to the Bacteroides phylum.
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The diagnostic criterion for amyotrophic lateral sclerosis (ALS) based on the findings of concomitant clinical and electrophysiological evidence of upper and lower motor neuron involvement may remain unsatisfied for months and in some patients, even for years in the early stage of the disease. Since respiratory involvement is an onset symptom of ALS in only 1-3% of patients, pulmonary assessment has never been considered useful in the early diagnosis of ALS. However, studies on pulmonary function are lacking, especially in those early stages where neurologic tests are also inconclusive. In contrast to the scarcity of data in the early stages, as the disease progresses, it is increasingly enriched by a rich set of symptoms and positive respiratory tests until respiratory failure occurs, which represents the main cause of death in ALS. Hereby we analyze the main pulmonary function tests (PFT) in the various stages of the disease, up to the recent evidence for the possibility of an early diagnosis.
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INTRODUCTION: Type 2 diabetes mellitus (T2DM) is a relevant risk factor for severe forms of COVID-19 (SARS coronavrus 2 [SARS-CoV-2] disease 2019), and calls for caution because of the high prevalence of T2DM worldwide and the high mortality rates observed in patients with T2DM who are infected with SARS-CoV-2. People with T2DM often take dipeptidyl peptidase-4 inhibitors (DPP-4is), glucagon-like peptide-1 receptor agonists (GLP-1ras), or sodium-glucose co-transporter-2 inhibitors (SGLT-2is), all of which have clear anti-inflammatory effects. The study aimed to compare (i) the severity and duration of hospital stay between patients with T2DM categorized by pre-hospitalization drug class utilization and (ii) the COVID-19-related death rates of those three groups. METHODS: We designed an observational, retrospective, multi-center, population-based study and extracted the hospital admission data from the health care records of 1916 T2DM patients over 18 years old who were previously on GLP-1ra, SGLT-2i, or DPP-4i monotherapy and were hospitalized for COVID-19 (diagnosis based on ICD.9/10 codes) between January 2020 and December 2021 in 14 hospitals throughout Italy. We analyzed general data, pre-admission treatment schedules, date of admission or transfer to the intensive care unit (ICU) (i.e., the index date; taken as a marker of increased COVID-19 disease severity), and death (if it had occurred). Statistics analyzed the impact of drug classes on in-hospital mortality using propensity score logistic regressions for (i) those admitted to intensive care and (ii) those not admitted to intensive care, with a random match procedure used to generate a 1:1 comparison without diabetes cohort replacement for each drug therapy group by applying the nearest neighbor method. After propensity score matching, we checked the balance achieved across selected variables if a balance was ever achieved. We then used propensity score matching between the three drug classes to assemble a sample in which each patient receiving an SGLT-2i was matched to one on a GLP-1ra, and each patient on a DPP-4i was matched to one on a GLP-1ra, adjusting for covariates. We finally used GLP-1ras as references in the logistic regression. RESULTS: The overall mortality rate (MR) of the patients was 14.29%. The MR in patients with COVID was 53.62%, and it was as high as 42.42% in the case of associated T2DM, regardless of any glucose-lowering therapy. In those on DPP-4is, there was excess mortality; in those treated with GLP-1ras and SGLT-2is, the death rate was significantly lower, i.e., almost a quarter of the overall mortality observed in COVID-19 patients with T2DM. Indeed, the odds ratio (OR) in the logistic regression resulted in an extremely high risk of in-hospital death in individuals previously treated with DPP-4is [incidence rate (IR) 4.02, 95% confidence interval (CI) 2.2-5.7) and only a slight, nonsignificantly higher risk in those previously treated with SGLT-2is (IR 1.42, 95% CI 0.6-2.1) compared to those on GLP-1ras. Moreover, the longer the stay, the higher the death rate, which ranged from 22.3% for ≤ 3-day stays to 40.3% for 4- to 14-day stays (p < 0.01 vs. the former) and 77.4% for over-14-day stays (p < 0.001 vs. both the others). DISCUSSION: Our data do not support a protective role of DPP-4is; indeed, this role has already been questioned due to previous observations. However, the data do show a strong protective effect of SGLT-2is and GLP-1ras. Beyond lowering circulating glucose levels, those two drug classes were found to exert marked anti-phlogistic effects: SGLT-2is increased adiponectin and reduced urate, leptin, and insulin concentrations, thus positively affecting overall low-grade inflammation, and GLP-1ras may also greatly help at the lung tissue level, meaning that their extra-glycemic effects extend well beyond those acknowledged in the cardiovascular and renal fields. CONCLUSIONS: The aforedescribed observational clinical data relating to a population of Italian inpatients with T2DM suggest that GLP-1ras and SGLT-2is can be considered antidiabetic drugs of choice against COVID-19, and might even prove beneficial in the event of any upcoming pandemic that has life-threatening effects on the pulmonary and cardiovascular systems.
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INTRODUCTION: Cutaneous lipohypertrophy (LH) is a thickened, "rubbery" lesion in the subcutaneous tissue following multiple injections performed at the same site, i.e., an incorrect injection technique. It is widespread, averaging 47% of insulin patients worldwide, and has severe direct and indirect consequences. Direct consequences consist mainly of poor metabolic control and frequent hypoglycemic events (HYPOs), and indirect ones of markedly increased healthcare costs related to hospital access due to acute events and long-term disease complications. This observation also holds for Italy, despite the National Health System organization expecting every patient with diabetes to undergo a series of visits by different care team members, each performing a specific treatment/education task. Indeed, the recent literature points to poor awareness of LH relevance and metabolic consequences among doctors from general and diabetic hospital wards, with educational deficiencies on correct injection practice in nurses too. The aim was to establish if, to what extent, and by whom they had received training on correct insulin injection techniques, and how many initially received notions had persisted over time. METHODS: We investigated the possible causes of such a failure from the point of view of 1160 insulin-requiring subjects with type 2 diabetes (T2DM), reporting for the first time to specialized diabetic structures through a validated questionnaire and, in the same patients, we searched for LH by inspection/palpation according to international guidelines, further confirmed by ultrasound scans. We then analyzed differences in education and injecting behavior between subjects classified as LH+ or LH- depending on the presence or absence of LH lesions. RESULTS: We documented significant educational gaps, with 50% of patients failing to refer to healthcare professionals and relying on their peers with diabetes, thought to be more experienced in 15% of the cases. Seventy-five percent of LH- patients received education from healthcare providers, while 90% of LH+ learned from another patient or could not remember how they knew, and 68% of LH+ versus 52% of LH- (p < 0.01) patients had failed to receive training on injection techniques by healthcare providers. All of this enabled the most disabling features of diabetes from the very beginning of the disease history. CONCLUSIONS: This study documents, from the patients' point of view, that educational gaps are significant and that, even in initially trained subjects, education on correct injection techniques has a fleeting effect if not regularly recalled. Therefore, to rehabilitate LH+ patients as soon as possible and prevent LH- patients from inadvertently slipping into the other group, there is an urgent need to educate doctors and nurses repeatedly on the importance of correctly injecting insulin to improve patients' knowledge and skills.
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OBJECTIVE: Uremia represents a state where hyperhomocysteinemia is resistant to folate therapy, thus undermining intervention trials' efficacy. N-acetylcysteine (NAC), an antioxidant, in addition to folates (5-methyltetrahydrofolate, MTHF), was tested in a population of hemodialysis patients. DESIGN: The study is an open, parallel, intervention study. SETTING: Ambulatory chronic hemodialysis patients. SUBJECTS: Clinically stable chronic hemodialysis patients, on hemodialysis since more than 3 months, undergoing a folate washout. Control group on standard therapy (n = 50). INTERVENTION: One group was treated with intravenous MTHF (MTHF group, n = 48). A second group was represented by patients treated with MTHF, and, during the course of 10 hemodialysis sessions, NAC was administered intravenous (MTHF + NAC group, n = 47). MAIN OUTCOME MEASURE: Plasma homocysteine measured before and after dialysis at the first and the last treatment. RESULTS: At the end of the study, there was a significant decrease in predialysis plasma homocysteine levels in the MTHF group and MTHF + NAC group, compared with the control group, but no significant difference between the MTHF group and MTHF + NAC group. A significant decrease in postdialysis plasma homocysteine levels in MTHF + NAC group (10.27 ± 0.94 µmol/L, 95% confidence interval: 8.37-12.17) compared with the MTHF group (16.23 ± 0.83, 95% confidence interval: 14.55-17.90) was present. In the MTHF + NAC group, 64% of patients reached a postdialysis homocysteine level <12 µmol/L, compared with 19% in the MTHF group and 16% in the control group. CONCLUSIONS: NAC therapy induces a significant additional decrease in homocysteine removal during dialysis. The advantage is limited to the time of administration.
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Acetilcisteína/administración & dosificación , Ácido Fólico/análogos & derivados , Hiperhomocisteinemia/tratamiento farmacológico , Diálisis Renal , Anciano , Quimioterapia Combinada , Femenino , Ácido Fólico/administración & dosificación , Homocisteína/sangre , Humanos , Hiperhomocisteinemia/etiología , Fallo Renal Crónico/complicaciones , Fallo Renal Crónico/terapia , Masculino , Persona de Mediana EdadRESUMEN
After examining the complex interplay between heart failure (HF) in its various clinical forms, metabolic disorders like nonalcoholic fatty liver disease (NAFLD), and obstructive sleep apnea (OSA) syndrome, in this mini-review we described possible favorable effects of sodium-glucose cotransporter 2 inhibitors (SGLT2is) on HF with preserved (i.e., ≥ 50%) ejection fraction (HFpEF) through enhanced cardiorenal function and visceral-subcutaneous body fat redistribution. In greater detail, on the basis of pathophysiological mechanisms underlying OSA onset and the direct positive SGLT2i effect on renal function benefiting chronic kidney disease, we emphasized the promising role of SGLT2is in prevention, rehabilitation, and treatment of patients with OSA regardless of coexisting type 2 diabetes (T2DM). Indeed, SGLT2is enhance lipolysis and fatty acid beta-oxidation. These phenomena might prevent OSA by reducing the size of visceral and subcutaneous adipose tissue and, as proven in humans and animals with T2DM, counteract NAFLD onset and progression. The aforementioned mechanisms may represent an additional SGLT2i cardioprotective effect in terms of HFpEF prevention in patients with OSA, whose NAFLD prevalence is estimated to be over 50%.
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Diabetes Mellitus Tipo 2 , Insuficiencia Cardíaca , Enfermedad del Hígado Graso no Alcohólico , Apnea Obstructiva del Sueño , Inhibidores del Cotransportador de Sodio-Glucosa 2 , Animales , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Ácidos Grasos/farmacología , Ácidos Grasos/uso terapéutico , Glucosa , Insuficiencia Cardíaca/complicaciones , Insuficiencia Cardíaca/tratamiento farmacológico , Humanos , Enfermedad del Hígado Graso no Alcohólico/epidemiología , Apnea Obstructiva del Sueño/complicaciones , Apnea Obstructiva del Sueño/tratamiento farmacológico , Sodio/farmacología , Sodio/uso terapéutico , Inhibidores del Cotransportador de Sodio-Glucosa 2/uso terapéutico , Volumen SistólicoRESUMEN
There is a close, physiological, relationship between kidney and lung that begin in the fetal age, and is aimed to keep homeostatic balance in the body. From a pathological point of view, the kidneys could be damaged by inflammatory mediators or by immune-mediated factors linked to a primary lung disease or, conversely, it could be the kidney disease that causes lung damage. Non-immunological mechanisms are frequently involved in renal and pulmonary diseases, as observed in chronic conditions. This crosstalk have clinical and therapeutic consequences. This review aims to describe the pulmonary-renal link in physiology and in pathological conditions.
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Vascular access is the lifeline for hemodialysis patients. Autologous artero-venous fistula (AVF) is still the most popular vascular access for hemodialysis even if declining during the last decades. Compared to central venous catheters and vascular grafts, AVF is characterized by a lower risk of infection and lower number of hospitalizations, and by a better quality of life, higher dialysis efficiency, and more prolonged life expectancy for patients. Since the year 1966 when the two surgeons Cimino and Brescia had the idea of connecting the forearm vein and artery for chronic dialysis, several data have accumulated on surgical procedures, positioning of AVF (distal vs proximal), time for the first use, monitoring and surveilling. All guidelines suggest that special care should be given by monitoring and surveilling AVF to avoid its failure or fatal closing. Attention should be paid to the patient's vasculature before surgery, through the "maturation" phase and chronic use. Indeed, AVF requires constant and careful care. The crucial role is played by the patient itself in cooperation with devoted clinical staff participated by skilled nurses, nephrologists, surgeons, radiologists, and sonographers. Literature on AVF is evaluated and guidelines suggestions reported as well as the data attained by the Accesso Vascolare per Emodialisi (AVE) project. This project aimed to evaluate the benefits of monitoring and surveilling, operated by a multidisciplinary team on dialysis adequacy, AVF longevity, and patient's mortality.
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Fístula Arteriovenosa , Derivación Arteriovenosa Quirúrgica , Catéteres Venosos Centrales , Derivación Arteriovenosa Quirúrgica/métodos , Humanos , Calidad de Vida , Diálisis Renal/métodosRESUMEN
BACKGROUND: Inflammation, oxidative stress (OS), atherosclerosis and resistant hypertension (RH) are common features of chronic kidney disease (CKD) leading to a higher risk of death from cardiovascular disease. These effects seem to be modulated by impaired anti-oxidant, anti-inflammatory and reverse cholesterol transport actions of high-density lipoprotein cholesterol (HDL). HDL prevents and reverses monocyte recruitment and activation into the arterial wall and impairs endothelial adhesion molecule expression. Recently, monocyte count to HDL-cholesterol ratio (MHR) has emerged as a potential marker of inflammation and OS, demonstrating to be relevant in CKD. Our research was aimed to assess, for the first time, its reliability in RH. METHODS: We performed a retrospective study on 214 patients with CKD and arterial hypertension who were admitted between January and June 2019 to our Department, 72 of whom were diagnosed with RH. RESULTS: MHR appeared inversely related to eGFR (ρ = - 0.163; P = 0.0172). MHR was significantly higher among RH patients compared to non-RH ones (12.39 [IQR 10.67-16.05] versus 7.30 [5.49-9.06]; P < 0.0001). Moreover, MHR was significantly different according to the number of anti-hypertensive drugs per patient in the whole study cohort (F = 46.723; P < 0.001) as well as in the non-RH group (F = 14.191; P < 0.001). Moreover, MHR positively correlates with diabetes mellitus (ρ = 0.253; P = 0.0002), white blood cells (ρ = 0.664; P < 0.0001) and C-reactive protein (ρ = 0.563; P < 0.0001). CONCLUSIONS: MHR may be a reliable biomarker due to the connection between HDL and monocytes. Our study suggests that MHR is linked with the use of multiple anti-hypertensive therapy and resistant hypertension in CKD patients, and can be a useful ratio to implement appropriate treatment strategies.
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HDL-Colesterol/sangre , Vasoespasmo Coronario/sangre , Hipertensión/sangre , Monocitos , Insuficiencia Renal Crónica/sangre , Anciano , Anciano de 80 o más Años , Biomarcadores/sangre , Vasoespasmo Coronario/complicaciones , Femenino , Humanos , Hipertensión/complicaciones , Masculino , Persona de Mediana Edad , Insuficiencia Renal Crónica/complicaciones , Estudios RetrospectivosRESUMEN
INTRODUCTION: The history of insulin-induced skin lipohypertrophy (LH) runs parallel to that of insulin's 100 years, and an average of 47% of insulin-treated patients still suffer from it today. The metabolic and economic effects of LH are significant, with hypoglycemia being the most striking. The objective of the study was to perform a 52-week follow-up of 713 insulin-treated patients with type 2 diabetes (T2DM) and LH to detect any differences in the occurrence of hypoglycemic events (HYPOs) and related healthcare costs as well as in LH rates and injection habits between an intensive education intervention group (IG) and control group (CG) provided with a single educational session at the starting point. METHODS: All participants were trained in accurately self-monitoring blood glucose and recording all HYPOs for 6 months, which allowed baseline recordings before they were randomized into the IG, comprising 395 insulin-treated subjects undergoing repeated, structured multimodal education on correct injection techniques as a longstanding behavioral rehabilitation strategy, and the CG, comprising 318 subjects receiving the same structured, multimodal educational session, but only initially. RESULTS: Changes in LH rate and size and in performance were large in the IG and only slight and transient in the CG. A striking difference in the rate of decrease of HYPOs was also apparent between groups. Indeed, estimated costs of health interventions for severe and symptomatic HYPOs, which were on the order of 70,000 and 9300, respectively, in the two groups at baseline decreased by 5.9 times and 13.7 times, respectively, at the end of follow-up in the IG and by only approximately half in the CG. Full details of the changes occurring as a result of intensive education are provided in the text. CONCLUSIONS: The effect of only initial education in the CG was not significant, thus providing evidence of the virtual worthlessness of a single training session on injection techniques, typical of worldwide daily clinical practice, and easily explaining the extremely high prevalence of LH in insulin-treated patients. Conversely, highly positive effects on LH prevalence and size as well as costs expected from decreased HYPO rate were obtained in the IG. To our knowledge, ours is the first 18-month randomized trial in the field. If our experimental model were to be used as an effective, longstanding behavioral rehabilitation strategy and therefore adapted to real-world settings universally, LH prevalence and costs related to their clinical consequences would be drastically reduced. However, only with a strong, relentless commitment of universities, scientific societies, and patient associations can we achieve this ambitious goal, which would provide great institutional savings and improved quality of life for people with diabetes.
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Diabetes Mellitus Tipo 2 , Insulina , Estrés Financiero , Humanos , Hipoglucemiantes/efectos adversos , Calidad de VidaRESUMEN
Several studies have shown that mineral metabolism disorders play a major role in determining a higher mortality rate for end-stage renal disease patients. Vitamin D deficiency is associated with cardiovascular events in hemodialysis patients. Recently, an association between vitamin D insufficiency and cardiovascular or renal events has been found, in patients with chronic renal failure who have not started renal replacement therapy yet. To further investigate this issue, we evaluated the relationship between blood levels of 25-hydroxyvitamin D (25-OH D; > or ≤30 ng/mL) and mortality or dialysis dependence in 104 incident consecutive patients with chronic kidney disease stages 3-5, over a period of 17 months, with a follow-up of 2 years in a cross-sectional analysis. The correlation between different levels of vitamin D and the risk of events has been estimated by using a probit model. Explanatory variables employed concerned age, sex, blood pressure, BMI, and number of co-morbid factors. The average 25-OH D concentration was of 30.13 ng/mL. During follow-up (>16 months), each patient experienced an average of 1.28 events. Vitamin D has been shown to reduce the probability of cardiovascular or renal events. Vitamin D intake for more than 12 months can reduce the probability of such events by 11.42%. Each co-morbid factor, instead, raises the probability of events by 29%. Lower probabilities of experiencing an adverse cardiovascular event might depend on higher levels of vitamin D. The influence of 25-OH D on survival in chronic kidney disease patients may be related to unrecognized factors that need to be further explored.
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Insuficiencia Renal Crónica/mortalidad , Deficiencia de Vitamina D/mortalidad , Vitamina D/análogos & derivados , Anciano , Anciano de 80 o más Años , Enfermedades Cardiovasculares/etiología , Estudios Transversales , Femenino , Hospitalización , Humanos , Italia/epidemiología , Masculino , Persona de Mediana Edad , Modelos Cardiovasculares , Insuficiencia Renal Crónica/sangre , Insuficiencia Renal Crónica/complicaciones , Vitamina D/sangre , Deficiencia de Vitamina D/complicacionesRESUMEN
Obstructive sleep apnoea (OSA) is characterized by frequent apnoea episodes during sleep due to upper airway obstruction. The present review summarizes current knowledge on inter-relationships between OSA and type 2 diabetes mellitus (T2DM) and suggests the former as a possible target for sodium-glucose co-transporter-2 inhibitors (SGLT-2i). Based on pathophysiological mechanisms underlying OSA onset and renal SGLT-2 effects, we suggest that SGLT-2i indications might expand beyond current ones, including glucose, lipids, uric acid, blood pressure, and body weight control as well as chronic heart failure and kidney disease prevention.
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Diabetes Mellitus Tipo 2 , Insuficiencia Cardíaca , Apnea Obstructiva del Sueño , Inhibidores del Cotransportador de Sodio-Glucosa 2 , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Glucosa , Humanos , Hipoglucemiantes , Apnea Obstructiva del Sueño/complicaciones , Inhibidores del Cotransportador de Sodio-Glucosa 2/uso terapéutico , Revisiones Sistemáticas como AsuntoRESUMEN
BACKGROUND: Diabetes mellitus (DM) is the leading cause of end-stage renal disease and 50% of dialysis patients are insulin-treated. AIM: to search for unexplained hypoglycemia (HYPO). METHODS: identify a possible cause of HYPO due to altered insulin absorption. RESULTS: insulin injected into subcutaneous lipo-hypertrophy (LH) nodules leads to unpredictable HYPOS. CONCLUSION: looking for LH systematically and training patients to the best injection technique are new challenges for nephrologists to reduce HYPO and emergency hospitalization rates, thus sparing healthcare resources and improving the quality of life of insulin-treated dialysis patients.
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Hipoglucemia/inducido químicamente , Hipoglucemiantes/efectos adversos , Insulina/efectos adversos , Lipoma/inducido químicamente , Diálisis Renal , Diabetes Mellitus/tratamiento farmacológico , Humanos , Inyecciones Intradérmicas , Fallo Renal CrónicoRESUMEN
INTRODUCTION: It is essential to use the correct injection technique (IT) to avoid skin complications such as lipohypertrophy (LH), local inflammation, bruising, and consequent repeated unexplained hypoglycemia episodes (hypos) as well as high HbA1c (glycated hemoglobin) levels, glycemic variability (GV), and insulin doses. Structured education plays a prominent role in injection technique improvement. The aim was to assess the ability of structured education to reduce (i) GV and hypos, (ii) HbA1c levels, (iii) insulin daily doses, and (iv) overall healthcare-related costs in outpatients with T2DM who were erroneously injecting insulin into LH. METHODS: 318 patients aged 19-75 years who had been diagnosed with T2DM for at least 5 years, were being treated with insulin, were routinely followed by a private network of healthcare centers, and who had easily seen and palpable LH nodules were included in the study. At the beginning of the 6-month run-in period (T-6), all patients were trained to perform structured self-monitoring of blood glucose and to monitor symptomatic and severe hypos (SyHs and SeHs, respectively). After that (at T0), the patients were randomly and equally divided into an intervention group who received appropriate IT education (IG) and a control group (CG), and were followed up for six months (until T+6). Healthcare cost calculations (including resource utilization, loss of productivity, and more) were carried out based on the average NHS reimbursement price list. RESULTS: Baseline characteristics were the same for both groups. During follow-up, the intra-LH injection rate for the CG progressively decreased to 59.9% (p < 0.001), a much smaller decrease than seen for the IG (1.9%, p < 0.001). Only the IG presented significant decreases in HbA1c (8.2 ± 1.2% vs. 6.2 ± 0.9%; p < 0.01), GV (247 ± 61 mg/dl vs. 142 ± 31 mg/dl; p < 0.01), insulin requirement (- 20.7%, p < 0.001), and SeH and SyH prevalence (which dropped dramatically from 16.4 to 0.6% and from 83.7 to 7.6%, respectively; p < 0.001). In the IG group only, costs-including those due to the reduced insulin requirement-decreased significantly, especially those relating to SeHs and SyHs, which dropped to 25.8 and 602.5, respectively (p < 0.001). CONCLUSION: Within a 6-month observation period, intensive structured education yielded consistently improved metabolic results and led to sharp decreases in the hypo rate and the insulin requirement. These improvements resulted in a parallel drop in overall healthcare costs, representing a tremendous economic advantage for the NHS. These positive results should encourage institutions to resolve the apparently intractable problem of LH by financially incentivizing healthcare teams to provide patients with intensive structured education on proper injection technique. TRIAL REGISTRATION: Trial registration no. 118/15.04.2018, approved by the Scientific and Ethics Committee of Campania University "Luigi Vanvitelli," Naples, Italy, and by the institutional review board (IRB Min. no. 9926 dated 05.05.2018).
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INTRODUCTION: Despite the availability of sophisticated devices and suitable recommendations on how to best perform insulin injections, lipohypertrophy (LH) and bruising (BR) frequently occur as a consequence of improper injection technique. AIM: The purpose of this nationwide survey was to check literature-reported LH risk factors or consequences for any association with BR METHOD: This was a cross-sectional, observational, multicenter study based on the identification of skin lesions at all patient-reported insulin injection sites in 790 subjects with diabetes. General and injection habit-related elements were investigated as possible BR risk factors. RESULTS: While confirming the close relationship existing between LH and a full series of factors including missed injection site rotation, needle reuse, long-standing insulin treatment, frequent hypoglycemic events (hypos), and great glycemic variability (GV), the observed data could find no such association with BR, which anyhow came with high HbA1c levels, missed injection site rotation, and long-standing insulin treatment. CONCLUSION: BR most likely depends on the patient's habit of pressing the injection pen hard onto the skin. Despite being worrisome and affecting quality of life, BR seems to represent a preliminary stage of LH but does not affect the rate of hypos and GV. TRIAL REGISTRATION: 207/19.09.2017.