Long-term impact of bariatric surgery on glycemic control and glucose-lowering therapy for people with type 2 diabetes: population-based cohort study.

BACKGROUND: Randomized controlled trials (RCTs) have demonstrated that bariatric surgery improves glycemic control among people with diabetes. However, evidence from RCTs may not be generalizable to real-world clinical care with unselected patients in routine clinical practice. OBJECTIVES: To examine long-term glycemic control and glucose-lowering drug regimens following bariatric surgery for people with type 2 diabetes (T2D) in unselected patients in routine clinical practice. SETTING: Population-based cohort study using linked routinely collected real-world data from Ontario, Canada. METHODS: Individuals with T2D who were assessed for bariatric surgery at any referral center in the province between February 2010 and November 2016 were identified and divided into those who received surgery within 2 years of the initial assessment and those who did not. RESULTS: There were 3674 people who had bariatric surgery and 1335 who did not. By 2 years, people who had undergone surgery had a significantly lower HbA1C (6.3 ± 1.2 % versus 7.8 ± 1.8 %, P < .0001), and this difference persisted at 3, 4, 5, and 6 years. Even by 6 years, half of those who had undergone surgery remained on no glucose-lowering drugs, and they were nearly 6 times less likely to be on insulin than those who had not undergone surgery. CONCLUSIONS: In real-world clinical care, bariatric surgery was associated with large and sustained improvements in glycemic control.

Buttonhole versus Stepladder Cannulation for Home Hemodialysis: A Multicenter, Randomized, Pilot Trial.

BACKGROUND AND OBJECTIVES: Canadian home hemodialysis guidelines highlight the potential differences in complications associated with arteriovenous fistula (AVF) cannulation technique as a research priority. Our primary objective was to determine the feasibility of randomizing patients with ESKD training for home hemodialysis to buttonhole versus stepladder cannulation of the AVF. Secondary objectives included training time, pain with needling, complications, and cost by cannulation technique. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: All patients training for home hemodialysis at seven Canadian hospitals were assessed for eligibility, and demographic information and access type was collected on everyone. Patients who consented to participate were randomized to buttonhole or stepladder cannulation technique. Time to train for home hemodialysis, pain scores on cannulation, and complications over 12 months was recorded. For eligible but not randomized patients, reasons for not participating in the trial were documented. RESULTS: Patient recruitment was November 2013 to November 2015. During this time, 158 patients began training for home hemodialysis, and 108 were ineligible for the trial. Diabetes mellitus as a cause of ESKD (31% versus 12%) and central venous catheter use (74% versus 6%) were more common in ineligible patients. Of the 50 eligible patients, 14 patients from four out of seven sites consented to participate in the study (28%). The most common reason for declining to participate was a strong preference for a particular cannulation technique (33%). Patients randomized to buttonhole versus stepladder cannulation required a shorter time to complete home hemodialysis training. We did not observe a reduction in cannulation pain or complications with the buttonhole method. Data linkages for a formal cost analysis were not conducted. CONCLUSIONS: We were unable to demonstrate the feasibility of conducting a randomized, controlled trial of buttonhole versus stepladder cannulation in Canada with a sufficient number of patients on home hemodialysis to be able to draw meaningful conclusions.

Physical Activity in Patients Treated With Peritoneal Dialysis: A Systematic Review and Meta-analysis.

BACKGROUND: Exercise has been shown to be of benefit in the general population and in patients with chronic diseases. Despite a lack of compelling evidence, patients with end-stage kidney disease (ESKD) treated with peritoneal dialysis (PD) are often discouraged from participating in exercise programs that include weight lifting due to concerns about the development of hernias and leaks. The actual effects of physical activity with or without structured exercise programs for patients on PD remain unclear. OBJECTIVE: To determine the risks and benefits of physical activity in the ESKD population treated with PD. DESIGN: Systematic review and meta-analysis. SETTING: Included all studies that met our criteria regardless of country of origin. PATIENTS: Adult patients with ESKD treated with PD. MEASUREMENTS: Descriptive and quantitative analysis of our primary and secondary outcome variables. METHODS: We searched MEDLINE, Embase, CINAHL, and Cochrane Central Register of Controlled Trials for observational and interventional studies examining the effects of physical activity in patients on PD. A systematic review and meta-analysis was conducted of the identified studies. The primary outcomes of interest included patient-centered outcomes of mental health, physical functioning, fatigue, quality of life, and adverse events. Secondary outcomes included nutritional measures, lipid profile, blood pressure changes, maximum heart rate, resting heart rate, maximal oxygen consumption, muscle development, cognitive function, and markers of inflammation. RESULTS: Of 1828 studies identified by the literature search, 12 met the inclusion criteria including 6 interventional and 6 observational studies. There was limited information on the patient important outcomes. However, there is some evidence for improvements in burden of kidney disease, physical function, and some mental health measures with physical activity. LIMITATIONS: Lack of well-designed randomized controlled trials impaired our ability to determine the benefits and risks of increasing physical activity. CONCLUSIONS: There is limited evidence of benefit with increased levels of physical activity in PD patients. Further research is needed to define the exercise program that is likely to be of most benefit to patients treated with PD.

CONTEXTE: Les bienfaits procurés par la pratique d'une activité physique sont démontrés tant dans la population générale que chez les patients souffrant de maladies chroniques. Pourtant, malgré un manque de données probantes à ce sujet, on déconseille souvent aux patients atteints d'insuffisance rénale terminale (IRT) et traités par dialyse péritonéale (DP) de prendre part à un programme d'entraînement incluant des exercices en résistance; on invoque notamment des préoccupations sur le développement d'une hernie ou de fuites. De plus, les effets réels de l'activité physique avec ou sans un programme structuré chez ces patients sont encore mal connus. OBJECTIF DE L'ÉTUDE: L'étude visait à mieux définir les risques et les bienfaits de la pratique d'une activité physique chez les patients atteints d'IRT et traités par DP. TYPE D'ÉTUDE: L'étude a été menée sous la forme d'une revue systématique de la littérature scientifique puis d'une méta-analyse. CADRE: Toutes les études satisfaisant nos critères, quel que soit leur pays d'origine, ont été incluses. PATIENTS: Tous les patients atteints d'IRT et traités par DP. MESURES: Nous avons procédé à l'analyse descriptive et quantitative des variables de nos paramètres primaires et secondaires. MÉTHODOLOGIE: Les bases de données MEDLINE, Embase et CINAHL, de même que le registre central Cochrane des essais cliniques randomisés ont été passés en revue afin d'y répertorier les études observationnelles et interventionnelles traitant des effets de l'activité physique chez les patients sous dialyse péritonéale. Une revue systématique et une méta-analyse des études retenues ont été effectuées. On s'est d'abord intéressé aux observations concernant la santé mentale du patient, son bien-être général, son niveau de fatigue et sa qualité de vie, de même qu'aux événements indésirables rapportés. Les résultats secondaires auxquels nous nous sommes attardés incluaient les mesures nutritionnelles, le profil lipidique, les variations dans la pression artérielle, la fréquence cardiaque maximale, la fréquence cardiaque au repos, la consommation maximale d'oxygène, le développement de la masse musculaire, les fonctions cognitives et les marqueurs de l'inflammation. RÉSULTATS: Des 1 828 études recensées par la revue de la littérature, seule une douzaine satisfaisait nos critères d'inclusion, soit 6 études interventionnelles et 6 études observationnelles. Il y avait très peu d'information au sujet des principaux résultats des patients. Néanmoins, on a pu constater l'existence de preuves attestant de l'allègement du fardeau posé par les maladies rénales et de l'amélioration des fonctions physiques et de certains aspects de la santé mentale par la pratique d'une activité physique. LIMITES DE L'ÉTUDE: Le faible nombre d'essais contrôlés, randomisés et bien conçus traitant de notre sujet nous a empêchés de bien mesurer les bienfaits et les risques associés à l'augmentation de l'activité physique. CONCLUSION: À ce jour, il existe encore peu de preuves que l'accroissement de l'activité physique procure des bienfaits aux patients traités par dialyse péritonéale. D'autres recherches sont nécessaires pour mieux définir les programmes d'exercice susceptibles de procurer le plus de bienfaits sur la santé des patients atteints d'IRT et traités par dialyse péritonéale.

A Pilot Study of OkKidney, a Phosphate Counting Application in Patients on Peritoneal Dialysis.

BACKGROUND: Hyperphosphatemia is associated with adverse outcomes in patients treated with peritoneal dialysis (PD). We have shown that a fixed meal phosphate binder dosing schedule is not appropriate. The purpose of this study was to evaluate the beta version of OkKidney, a phosphate counting app that matches meal phosphate content with binder dose. METHODS: A convenience sample of adult patients treated with PD completed a pre-survey that included the technology readiness index (TRI 2.0). After a short information session, patients used OkKidney for 30 days. Pre- and post-intervention serum calcium, serum phosphate, and calcium carbonate binder intake were collected and compared using a paired t-test. A post-intervention survey using a 5-point Likert scale was used to gather patient feedback. RESULTS: Ten patients (5M, 5F) completed the study protocol. Participants were 55 ± 17 years old, predominately Caucasian, retired (60%), and owned a smartphone (70%). The median TRI score was 3.66 (max 5), indicating a moderate level of readiness. The post-survey results indicated a favorable rating for ease of use (µ = 4.4 ± 0.84) and usefulness (µ = 4.3 ± 0.68) of OkKidney. The average serum phosphate (p = 0.99) and calcium (p = 0.68) were not different pre-/post-intervention, but calcium carbonate intake tended to decrease (p = 0.12). CONCLUSION: Patients reported a positive experience with OkKidney. Further patient-specific adjustments of the binder dose to meal phosphate content may be required to demonstrate a statistically significant decrease in phosphate levels. We believe a larger trial is warranted to investigate the clinical implications of this app.

Physical Activity in Patients Treated With Peritoneal Dialysis: A Protocol for a Systematic Review.

BACKGROUND: Patients with chronic diseases are known to benefit from exercise. Despite a lack of compelling evidence, patients with end-stage kidney disease treated with peritoneal dialysis are often discouraged from participating in exercise programs that include resistance training due to concerns about the development of hernias and leaks. The actual effects of physical activity with or without structured exercise programs for these patients remain unclear. The purpose of this study is to more completely define the risks and benefits of physical activity in the end-stage kidney disease population treated with peritoneal dialysis. METHODS/DESIGN: We will conduct a systematic review examining the effects of physical activity on end-stage kidney disease patients treated with peritoneal dialysis. For the purposes of this review, exercise will be considered a purposive subcategory of physical activity. The primary objective is to determine if physical activity in this patient population is associated with improvements in mental health, physical functioning, fatigue and quality of life and if there is an increase in adverse outcomes. With the help of a skilled librarian, we will search MEDLINE, EMBASE, CINAHL, and Cochrane Central Register of Controlled Trials for randomized trials and observational studies. We will include adult end-stage kidney disease patients treated with peritoneal dialysis that have participated in an exercise training program or had their level of physical activity assessed directly or by self-report. The study must include an assessment of the association between physical activity and one of our primary or secondary outcomes measures. We will report study quality using the Cochrane Risk of Bias Assessment Tool for randomized controlled trials and the Newcastle-Ottawa Scale for observational studies. Quality across studies will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. The results of this review may help to inform guideline development for exercise recommendations specific to this patient population. SYSTEMATIC REVIEW REGISTRATION: PROSPERO:CRD42016041695.

MISE EN CONTEXTE: Les bienfaits procurés par l'exercice physique chez les patients souffrant de maladies chroniques sont connus. Pourtant, malgré l'absence de données probantes, on conseille souvent aux patients atteints d'insuffisance rénale terminale (IRT) et sous dialyse péritonéale d'éviter de prendre part à un programme d'entraînements incluant des exercices en résistance, en raison de préoccupations sur le développement d'une hernie ou de fuites. Les effets réels de l'activité physique avec ou sans un programme structuré chez ces patients sont encore mal connus. L'objectif de cette étude est de mieux définir les risques et les bienfaits de l'activité physique dans la population de patients atteints d'IRT et traités par dialyse péritonéale. MÉTHODOLOGIE/CONCEPTION DE L'ÉTUDE: Nous procèderons à une revue systématique de la littérature examinant les effets de l'activité physique chez les patients atteints d'IRT et traités par dialyse péritonéale. Aux fins de la présente analyse, un entraînement sera considéré comme une sous-catégorie de l'activité physique. L'objectif principal est de déterminer si l'activité physique chez ces patients est associée à une amélioration de la santé mentale, du bien-être physique en général, du niveau de fatigue et de la qualité de vie. On veut également vérifier si la pratique d'une activité physique provoque une augmentation des conséquences indésirables. Avec l'aide d'un bibliothécaire expérimenté, nous consulterons le Cochrane Central Register of Controlled Trials ainsi que les bases de données MEDLINE, EMBASE et CINAHL afin de répertorier les essais cliniques randomisés et les études observationnelles traitant du sujet. Nous inclurons des adultes atteints d'IRT traités par dialyse péritonéale suivant un programme d'exercices ou des patients dont le niveau d'activité physique aura été évalué directement ou par auto-évaluation. L'étude devra inclure une évaluation de l'association entre la pratique d'une activité physique et l'un de nos critères principal ou secondaire. La qualité des études retenues sera évaluée: les essais cliniques contrôlés randomisés seront évalués à l'aide de l'outil Cochrane qui mesure les risques de biais, et les études observationnelles le seront avec l'échelle de Newcastle ­ Ottawa. De même, la qualité des données recueillies au cours de l'étude sera évaluée au moyen de la méthodologie GRADE. Les résultats de cet examen pourront guider l'élaboration de lignes directrices et des recommandations pour la pratique d'une activité physique chez cette population de patients spécifique. ENREGISTREMENT DE LA REVUE SYSTÉMATIQUE: Prospero CRD42016041695.

Diabetes Mellitus and Younger Age Are Risk Factors for Hyperphosphatemia in Peritoneal Dialysis Patients.

Hyperphosphatemia has been associated with adverse outcomes in patients with end stage kidney disease (ESKD). The purpose of this study was to determine risk factors for hyperphosphatemia in ESKD patients treated with peritoneal dialysis (PD). This information will be used to develop a patient specific phosphate binder application to facilitate patient self-management of serum phosphate. Adult PD patients documented their food, beverage, and phosphate binder intake for three days using a dietitian developed food journal. Phosphate content of meals was calculated using the ESHA Food Processor SQL Software (ESHA Research, Salem, UT, USA). Clinic biochemistry tests and an adequacy assessment (Baxter Adequest program) were done. Univariate logistic regression was used to determine predictors of serum phosphate >1.78 mmol/L. A multivariable logistic regression model was then fit including those variables that achieved a significance level of p < 0.20 in univariate analyses. Sixty patients (38 men, 22 women) completed the protocol; they were 60 ± 17 years old, 50% had a history of diabetes mellitus (DM) and 33% had hyperphosphatemia (PO4 > 1.78 mmol/L). In univariate analysis, the variables associated with an increased risk of hyperphosphatemia with a p-value < 0.2 were male gender (p = 0.13), younger age (0.07), presence of DM (0.005), higher dose of calcium carbonate (0.08), higher parathyroid serum concentration (0.08), lower phosphate intake (0.03), lower measured glomerular filtration rate (0.15), higher phosphate excretion (0.11), and a higher body mass index (0.15). After multivariable logistic regression analysis, younger age (odds ratio (OR) 0.023 per decade, 95% confidence interval (CI) 0.00065 to 0.455; p = 0.012), presence of diabetes (OR 11.40, 95 CI 2.82 to 61.55; p = 0.0003), and measured GFR (OR 0.052 per mL/min decrease; 95% CI 0.0025 to 0.66) were associated with hyperphosphatemia. Our results support that younger age and diabetes mellitus are significant risk factors for hyperphosphatemia. These findings warrant further investigation to determine the potential mechanisms that predispose younger patients and those with DM to hyperphosphatemia.

Meal phosphate variability does not support fixed dose phosphate binder schedules for patients treated with peritoneal dialysis: a prospective cohort study.

BACKGROUND: Removal of phosphate by peritoneal dialysis is insufficient to maintain normal serum phosphate levels such that most patients must take phosphate binders with their meals. However, phosphate 'counting' is complicated and many patients are simply prescribed a specific dose of phosphate binders with each meal. Therefore, our primary objective was to assess the variability in meal phosphate content to determine the appropriateness of this approach. METHODS: In this prospective cohort study, adult patients with ESRD treated with peritoneal dialysis and prescribed phosphate binder therapy were eligible to participate. Participants were excluded from the study if they were unable to give consent, had hypercalcemia, were visually or hearing impaired or were expected to receive a renal transplant during the time of the study. After providing informed consent, patients kept a 3-day diet diary that included all foods and beverages consumed in addition to portion sizes. At the same time, patients documented the amount of phosphate binders taken with each meal. The phosphate content of the each meal was estimated using ESHA Food Processor SQL Software by a registered dietitian. Meal phosphate and binder variability were estimated by the Intra Class Correlation Coefficient (ICC) where 0 indicates maximal variability and 1 indicates no variability. RESULTS: Seventy-eight patients consented to participate in the study; 18 did not complete the study protocol. The patients were 60 (± 17) years, predominately male (38/60) and Caucasian (51/60). Diabetic nephropathy was the most common cause of end stage kidney disease. The daily phosphate intake including snacks ranged from 959 ± 249 to 1144 ± 362 mg. The phosphate ICC by meal: breakfast 0.63, lunch 0.16; supper 0.27. The phosphate binder ICC by meal: breakfast 0.68, lunch 0.73, supper 0.67. CONCLUSION: The standard prescription of a set number of phosphate binders with each meal is not supported by the data; patients do not appear to be adjusting their binders to match the meal phosphate content. An easy to use phosphate counting program that assists the patient in determining the appropriate amount of phosphate binder to take may enhance phosphate control.