Progress 10/01/12 to 09/30/17
Outputs
Target Audience:The primary target audience consists of patients with kidney failure undergoing chronic hemodialysis therapy. Changes/Problems:
Nothing Reported
What opportunities for training and professional development has the project provided?At least threePhD students in my laboratory contributed to this work over the entire life of the project. While the funding did not provide salary support for all of them, the project support was critical to their dissertation projects that ultimately led to them obtaining a PhD in either nutrition or kinesiology. How have the results been disseminated to communities of interest?Some results from this study were presented as poster presentations at the American Society of Nephrology in 2017. What do you plan to do during the next reporting period to accomplish the goals?
Nothing Reported
Impacts
What was accomplished under these goals?
We are currently writing up a manuscript related to our findings from this study. Related to our primary hypotheses, we have found the following:1) eating during dialysis does NOT impact the efficiency of the dialysis treatment; and 2) it has only a transient effect on blood pressure.These are important findings because eating is often restricted during treatment for these hypothesized concerns (reduced efficiencyand low blood pressure/"intradialytic hypotension").However, our data indicates that thereis no rationale for these restrictions on eating during treatment. By contrast, our data provides evidence that eating during treatment is safe, and should be encouraged to help offset some of the catabolic effects of dialysis therapy. As for hypothesis number three, we were also able to demonstrate that exercise during dialysisdoes NOT exacerbate the effects of intradialytic feeding.In other words, exercise does NOT cause additional hemodynamic stress during treatment.
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Progress 10/01/15 to 09/30/16
Outputs
Target Audience:Our target audience is patients with kidney failure undergoing chronic hemodialysis (HD) treatment. These patients suffer from a variety of co-morbidities, including cardiovascular disease, muscle wasting, and bone and mineral disorders. Changes/Problems:
Nothing Reported
What opportunities for training and professional development has the project provided?As noted above, this work has been the major focus of the dissertation projects for three of my PhD students. Furthermore, abstracts related to this work have been submitted to 3 professional meetings that will be held this fall. Two of the abstracts will be presented at Renal Research Institutes International Conference on Dialysis in Las Vegas in January, 2017. A third one will be submitted to the American Society of Nephrology Meeting in May, 2017. How have the results been disseminated to communities of interest?Only in abstract form, for presentation at professional meetings (described above). What do you plan to do during the next reporting period to accomplish the goals?We are continuing our ongoing work assessing the effects of dietary fiber supplementation on bone and mineral metabolism in hemodialysis patients. This work will comprise the bulk of our efforts in the next year.
Impacts
What was accomplished under these goals?
We have two manuscripts in preparation related to this work. The first is related to Aim 1 and Aim 2, while the second manuscript is related to Aim 3. These two manuscripts should both be submitted in January 2017. They were the major topics for the doctoral dissertations for two of my PhD students. The first of these students, Brandon Kistler, successfully defended his dissertation earlier this year. The second student, Jinny Jeong, will defend her disseration work in December. A third project associated with this research is ongoing. The purpose of this work is to assess the effects of dietary fiber supplementation on bone and mineral metabolism in hemodialysis patients. Twelve patients were recruited for this trial and are in various stages of the intervention.
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Progress 10/01/14 to 09/30/15
Outputs
Target Audience:Patients with kidney failure receiving maintenance hemodialysis therapy are the target audience for this project. These patients suffer from a plethora of co-morbid conditions, including malnutrition and muscle wasting. Our project is designed to test the efficacy of an approach to mitigate these problems. Changes/Problems:The long-term objective of our research is to improve the nutritional status and quality of life through lifestyle (nutrition and exercise) interventions in maintenance hemodialysis patients. As such, we have begun a new project that is an extension of our previous project. The objective of both studies is to examine the efficacy and feasibility of nutrition and exercise interventions in this clinical population. As such, our new proposal is focused on the gut microbiota-mediated effects of a fermentable fiber (inulin) on mineral metabolism in maintenance hemodialysis patients, which is highly prevalent in chronic-kidney disease patients (up to 80%) and increases the risk of morbidity and mortality of this population. Our previous study aimed to examine the acute effects of intradialytic feeding on treatment efficiency and hemodynamic responses, since the dialysis treatment provides a critical time for interventions aiming at improving the nutritional status of maintenance hemodialysis patients. Although the latter study is an acute intervention (3 consecutive hemodialysis treatments) and the former is a short-term supplementation study (cross-over design with two 4-week intervention periods), both of these are aimed to be exploratory projects to assess the feasibility of low-cost nutritional interventions that can be added to the standard of care to improve nutritional status and quality of life of maintenance hemodialysis patients. What opportunities for training and professional development has the project provided?Brandon Kistler, PhD candidate, and co-investigator on this project, presented an abstract related to this work at the National Kidney Foundations Clinical Meetings in Dallas, Texas in April 2015. The title of his abstract was: "A scale to measure gastrointestinal symptoms associated with a single hemodialysis treatment: Validation and association with dietary intake during treatment." Authors: Brandon Kistler (Co-I), Karen Chapman-Novakfski (Co-I), and Kenneth Wilund (PI). How have the results been disseminated to communities of interest?See above - An abstract was presented to the National Kidney Foundation Clinical Meetings. What do you plan to do during the next reporting period to accomplish the goals?We have several more patients to recruit for our original study. The data collection on this first study should be completed by February. We will then analyze the data and submit the findings for publication in the Spring of 2016. As described in the next section (under modifications), we will soon begin a second project related to our initial study.
Impacts
What was accomplished under these goals?
To ensure high quality data with the possibility of publication, we recruited 20 additional participants (new total n=48) for the validation of our measure of GI symptoms (Age 56 ± 13, Diabetes 54.2%, Male 62.5%). In general, we still found good agreement between items in each domain and repeatability among individual domains. Prevalence of GI symptoms during treatment (77.1%) was much higher than previously reported and associated with the intake of fat (r=.318, p = 0.027) and fiber (.386, p = 0.007) during treatment. Carbohydrates and lipids have been previously implicated as the primary cause of postprandial drops in blood pressure and GI symptoms during hemodynamic instability. Therefore, we continued our progression towards solid meals and applied the same within-subjects model as our original study with protein to test for the effect of a renal specific mixed-macronutrient supplement. We baseline tested 11 HD patients to determine cardiovascular structure and function. These measurements included autonomic function, cardiac and arterial ultrasound, measures of blood pressure and wave reflection, and an exercise challenge. Following baseline testing, we monitored a standard HD treatment (HD) and a standard HD treatment in which patients consumed a nutrition supplement (HD + ONS). HD + ONS resulted in a trend for an increase in blood glucose (p = 0.061) compared to HD. Despite this increase in glucose, a potentially vasoactive compound, we found no interactions among any hemodynamic variable (p>0.05 for all) in the HD + ONS compared to HD. While there were no interactions, postprandial beat-to-beat cardiac output and heart rate were elevated in the HD + ONS group compared to the HD group (p < 0.05) over the 150 minutes following supplementation. In spite of these hemodynamic alterations, we found no statistical difference between any measure of treatment efficiency or GI symptoms between HD and HD + ONS (p > 0.05 for all). When we compared the maximum change in BP following ONS with treatment characteristics, cardiovascular structure, and cardiovascular function, we found only baseline baroreceptor sensitivity was associated with the change in MAP (r=0.706, p=0.05).
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Progress 10/01/13 to 09/30/14
Outputs
Target Audience: Patients with kidney failure receiving maintenance hemodialysis therapy are the target audience for this project. These patients suffer from a plethora of co-morbid conditions, including malnutrition and muscle wasting. Our project is designed to test the efficacy of an approach to mitigate these problems. Changes/Problems: As described in our accomplishments section, the dialysis clinic that we are recruiting patients from for this study has recommended major changes to our protocol along the way, based on some perceived safety concerns they had with feeding patients during their dialysis treatment. We have worked hard to address these concerns by adopting an iterative protocol for this project. What opportunities for training and professional development has the project provided? Several graduate students in my laboratory have been helping conduct this research. This includes recruiting patients and data collection and analysis. This project is a critical component of their graduate research training. How have the results been disseminated to communities of interest?
Nothing Reported
What do you plan to do during the next reporting period to accomplish the goals? While our original protocol involved examining the effects of a mixed-macronutrient solid meal on dialysis efficiency and hemodynamic parameters, we were forced to first test the safety and efficacy of a liquid protein beverage on hemodialysis efficiency and hemodynamic parameters. We have now moved to feeding our patients a mixed macronutrient, renal-specific beverage of higher caloric content to the patients. While this work is still ongoing, this process was necessary to allay the concerns that our clinic had after undergoing an internal research audit that briefly shut down all research at their clinics. Assuming we demonstrate safety and efficacy of this mixed macronutrient beverage, we will then complete the original proposed treatment, which is a solid meal, with and without concomitant exercise. While these problems have slowed the achievement of our original aims, the data we have been able to collect has been critical to addressing these safety concerns, and has allowed us the opportunity to continue with this work.
Impacts
What was accomplished under these goals?
Soon after this project was funded, the corporation that manages the hemodialysis clinics we were recruiting patients from underwent an internal research audit. While they continued to support our research efforts, they required us to make some changes in our protocols due to some patient safety concerns they had related to eating and exercising during dialysis. Among the changes that were requested was the addition of a measurement of gastrointestinal symptoms associated with each of the treatments. Because we were unable to find a validated measure to accomplish this new goal, we adapted a readily available tool (the Gastrointestinal Symptom Rating Scale) to measure acute symptoms associated with a single hemodialysis treatment. To ensure that this tool could be used to measure acute symptoms we conducted a validation study. We first sent the survey to five renal dietitians from around the country for comments. After incorporating their comments, we enrolled 30 hemodialysis patients (55 ± 15 years, 63.3% male, 50% diabetic) and measured symptoms associated with three domains (heartburn, indigestion, and abdominal pain (9 total questions)) immediately following a HD session. During this treatment, we also monitored everything that patients had to eat or drink by diet recall using the USDA 5-pass method. In addition, we measured two domains (diarrhea and constipation (6 total questions)) over the 48-72 hours between HD treatments. Three weeks later we repeated this protocol to measure reliability. We found that internal consistency (Cronbach’s alpha) was acceptable (indigestion) or good (abdominal pain, diarrhea, constipation). Significant correlations were found between repeated measures in each of the GI domains (p < 0.05) with the exception of abdominal pain (p = 0.13). Intake of fat (r=.277, p < 0.04) and fiber (r=.360, p < 0.01) during the treatment was associated with indigestion, but no other significant correlations existed between dietary intake and GI symptoms. Therefore, we concluded that this was a reliable and valid tool to measure GI symptoms associated with a single hemodialysis treatment. It was also suggested that we add a measure that estimates central arterial pressure. To accomplish this, we researched and found a system that estimates central pressures using a cuff-based system (Mobil-O-Graph, IEM, Germany). The tool also measures central arterial stiffness, and allows measurements of wave reflection and arterial stiffness within the privacy requirements of a hemodialysis clinic. We have successfully piloted this equipment and are now collecting this data as part of our ongoing research efforts. Another change the dialysis clinic made was to significantly alter the way that we were allowed to collect our dialysate, in brief, to mitigate potential biohazard concerns during dialysate collection at the clinic. We worked diligently with the hemodialysis clinic staff to build and pilot a partial dialysate collection device that will comply with the necessary regulatory requirements within the state of Illinois and require only minimal staff involvement. Our original protocol involved examining the effects of a mixed-macronutrient solid meal on dialysis efficiency and hemodynamic parameters. However, based again on concerns raised by the clinic, we adopted an interative approach to our study design to alleviate the safety concerns they had. The approach we adopted was to first test the safety and effects of ingestion of a liquid protein beverage on these outcomes. We have now completed this initial pilot study and indeed found that this was safe (no adverse events such as hypotensive events or aspiration). We are now in the process of feeding a mixed macronutrient, renal-specific beverage of higher caloric content to the patients. Assuming we demonstrate safety and efficacy with this type of meal, we will then complete the original proposed treatment, which is a solid meal with and without concomitant exercise. In summary, the corporation that manages our dialysis clinic forced a number of changes to our protocol that both delayed and significantly changed our approach. However, we have made significant progress related to these goals, and continue to pursue this work through other funding mechanisms that we have applied for.
Publications
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Progress 10/01/12 to 09/30/13
Outputs
Target Audience: Patients with kidney failure receiving maintenance hemodialysis therapy are the target audience for this project. These patients suffer from a plethora of co-morbid conditions, including malnutrtion and muscle wasting. Our project is designed to test the efficacy of an approach to mitigate these problems. Changes/Problems:
Nothing Reported
What opportunities for training and professional development has the project provided? Several graduate students in my laboratory have been helping conduct this research. This includes recruiting patients, as well as data collection and analysis. This project is a critical component of their graduate research training. How have the results been disseminated to communities of interest?
Nothing Reported
What do you plan to do during the next reporting period to accomplish the goals? We will continue recruiting patients into the study on a rolling basis. To prevent any biased interpretation of the data, we will NOT analyze our primary outcomes until the project is completed. We expect to complete all enrollment and testing by the end of the next reporting period (in one year). Following data analysis, we plan to submit the research for publication in professional journals, and present results at scientific conferences. Furthermore, the data from this pilot project will be used as pilot data to support the submission of additional grant applications to extramural agencies.
Impacts
What was accomplished under these goals?
Accomplishments to date: Received approval to conduct the study from the University of Illinois Institutional Review Board on 1/31/2013. However, we did not receive approval from Renal Research Institute, the company that manages the Hemodialysis clinic where the patients are treated, until July 2013, primarily due to an internal audit of all of their research protocols. Webegan patient recruitment and testing in September, 2013. A total of 8 patients have enrolled in the study to date. 4 have completed all protocols, with 3 more scheduled to finish by the end of December, 2013. We have not conducted any significant preliminary data analysis due to the low number of patients that are finished with the study.
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