Ignite Creation Date:
2024-05-06 @ 10:09 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03189758
Status:
UNKNOWN
Last Update Posted:
2020-08-03
First Post:
2017-06-14
Brief Title:
Dietary Sodium DS Intervention to Reduce Volume Overload and Tissue Sodium in Magnetic Resonance Imaging MRI for Hemodialysis HD Patients
Sponsor:
University of Illinois at Urbana-Champaign
Organization:
University of Illinois at Urbana-Champaign
Study Overview
Official Title:
Dietary Sodium DS Intervention to Reduce Volume Overload and Tissue Sodium in Magnetic Resonance Imaging MRI for Hemodialysis HD Patients
Status:
UNKNOWN
Status Verified Date:
2020-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DSMRI
Brief Summary:
Sodium-adapted magnetic resonance imaging 23Na-MRI studies have demonstrated that sodium accumulates in certain tissues including the skin and skeletal muscle but may be manipulated by lifestyle factors or therapeutic interventions such as a hemodialysis HD session This tissue sodium accumulation is increased with age and in the presence of certain chronic diseases such as renal failure and may contribute to the development of high blood pressure It currently not known what the impact of dietary sodium consumption has on tissue sodium in HD patients and on the subsequent risk of cardiovascular complications either acutely or chronically The University of Illinois Biomedical Imaging Center recently completed safety testing on a 23Na-MRI coil that they modified for measuring skin and muscle sodium levels in the lower legcalf that will be used for assessing the impact of dietary salt restriction on tissue sodium levels
Detailed Description:
Recent studies illustrate that tissue sodium is regulated by immune cells in interstitial fluids such as the skin and muscle Localized immune responses in these tissues can promote vascular endothelial growth factor secretion to promote lymphatic release of fluid and electrolytes which has significant implications for blood pressure control and cardiovascular health Furthermore sodium composition of the diet has the potential to promote beneficial gut bacteria in addition to lowering auto-immune response and blood pressure
The purpose of this pilot study is to utilize this 21Na-MRI coil to quantify changes of sodium levels in the skin and skeletal muscle in hemodialysis treatments before and after a low-sodium diet intervention In this study all HD patients will undergo a 30-day observation period CON followed by a low-sodium diet period INT for 30 additional days Testing will occur at baseline and after each time-point three time points total During the CON period patients will have no changes to their normal dialysis treatment and will be asked to follow their normal diet During the INT period patients will provided a low- sodium diet intervention that includes receiving 3 low sodium meals per day and snacks provided by momsmealscom
The study outcomes include clinical outcomes hospitalizations treatment efficiency changes in tissue sodium cardiovascular measures blood pressure cardiac output and vascular resistance and fluidhydration status total body water extracellular fluid using bioelectrical impedance We will also collect serum to analyze the relationship between changes in tissue sodium and serum minerals eg sodium and potassium and other factors believed to help regulate tissue sodium levels including vascular endothelial growth factor VEGF and markers of inflammation CRP IL-6 Additionally we plan to collect patient stool samples to analyze how changes in dietary sodium consumption impact the gut microbiome
This study will demonstrate the feasibility of utilizing 23Na-MRI to quantify skin and muscle sodium levels as well as provide pilot data regarding the relationship between tissue sodium accumulation inflammation the gut microbiome insulin resistance and cardiovascular health in hemodialysis patients Results from this study will then be used to design larger trials to investigate related questions
The purpose of this pilot study is to utilize this 21Na-MRI coil to quantify changes of sodium levels in the skin and skeletal muscle in hemodialysis treatments before and after a low-sodium diet intervention In this study all HD patients will undergo a 30-day observation period CON followed by a low-sodium diet period INT for 30 additional days Testing will occur at baseline and after each time-point three time points total During the CON period patients will have no changes to their normal dialysis treatment and will be asked to follow their normal diet During the INT period patients will provided a low- sodium diet intervention that includes receiving 3 low sodium meals per day and snacks provided by momsmealscom
The study outcomes include clinical outcomes hospitalizations treatment efficiency changes in tissue sodium cardiovascular measures blood pressure cardiac output and vascular resistance and fluidhydration status total body water extracellular fluid using bioelectrical impedance We will also collect serum to analyze the relationship between changes in tissue sodium and serum minerals eg sodium and potassium and other factors believed to help regulate tissue sodium levels including vascular endothelial growth factor VEGF and markers of inflammation CRP IL-6 Additionally we plan to collect patient stool samples to analyze how changes in dietary sodium consumption impact the gut microbiome
This study will demonstrate the feasibility of utilizing 23Na-MRI to quantify skin and muscle sodium levels as well as provide pilot data regarding the relationship between tissue sodium accumulation inflammation the gut microbiome insulin resistance and cardiovascular health in hemodialysis patients Results from this study will then be used to design larger trials to investigate related questions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None