Dietary Sodium (DS) Intervention to Reduce Tissue Sodium in Hemodialysis (HD) Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/4/2018 |
| Start Date: | June 19, 2017 |
| End Date: | December 31, 2020 |
| Contact: | Luis M Perez, BS |
| Email: | lmperez2@illinois.edu |
| Phone: | 7192444805 |
Dietary Sodium (DS) Intervention to Reduce Tissue Sodium in Magnetic Resonance Imaging (MRI) for Hemodialysis (HD) Patients
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 patient's 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 leg/calf that will be used for assessing the impact of dietary
salt restriction on tissue sodium levels.
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 patient's 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 leg/calf that will be used for assessing the impact of dietary
salt restriction on tissue sodium levels.
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 momsmeals.com.
The study outcomes include: clinical outcomes (hospitalizations, treatment efficiency)
changes in tissue sodium, cardiovascular measures (blood pressure, cardiac output, and
vascular resistance) and fluid/hydration 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 (e.g. 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.
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 momsmeals.com.
The study outcomes include: clinical outcomes (hospitalizations, treatment efficiency)
changes in tissue sodium, cardiovascular measures (blood pressure, cardiac output, and
vascular resistance) and fluid/hydration 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 (e.g. 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.
Inclusion Criteria:
- Willingness to sign informed consent document and age 18 or greater.
- Willingness to consume intervention meals 3 times per day (with provided snacks) for
30 days.
Exclusion Criteria:
1. Individuals with pacemakers
2. Individuals with amputations
3. Individuals with metal implants or devices in the body
4. Subjects weighing greater than 110 kilograms
5. Claustrophobic individuals
6. Individuals that do not otherwise meet MRI screening requirements (mentioned below)
7. Individuals on HD therapy <3 days per week or <3 months
8. Currently following a sodium restricted diet <2,300 mg per day
9. Currently diagnosed GI disorder or disease
We found this trial at
1
site
Urbana, Illinois 61801
Principal Investigator: Ken Wilund, PhD
Phone: 217-265-6755
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