Skip to content

Dietary Sodium (DS) Intervention to Reduce Volume Overload and Tissue Sodium in Magnetic Resonance Imaging (MRI) for Hemodialysis (HD) Patients

Dietary Sodium (DS) Intervention to Reduce Volume Overload and Tissue Sodium in Magnetic Resonance Imaging (MRI) for Hemodialysis (HD) Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03189758
Acronym
DSMRI
Enrollment
20
Registered
2017-06-16
Start date
2017-06-19
Completion date
2021-12-31
Last updated
2020-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Modification, Kidney Failure, Chronic

Keywords

chronic kidney disease, hemodialysis, sodium restriction, MRI

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 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.

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 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.

Interventions

OTHERObservational Control Diet

Participants will follow their usual or normal diet for 30 days (days 1-30) while under study observation.

Participants will be provided with all meals and snacks daily, for 30 days (days 31-60). These meals should meet KDQOI guidelines for energy and protein (30-35 kcal/kg & 1.2 g/kg) as well as low phosphorus, potassium, and sodium. The meals are formulated to less than 600-800 mg sodium each (\<2,000g/day) and will be ordered and delivered through momsmeals.com

Sponsors

Renal Research Institute
CollaboratorOTHER
University of Illinois at Urbana-Champaign
Lead SponsorOTHER

Study design

Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Observational control followed by dietary intervention

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 (exclusion from cardiovascular testing only) 2. Individuals with major amputations (i.e. whole limb: foot, ankle, leg, arm) 3. Individuals with ferric metal implants or devices in the body (excluded from MRI testing only) 4. Claustrophobic individuals (excluded from MRI testing only) 5. Individuals that do not otherwise meet MRI screening requirements (mentioned below, excluded from MRI testing only) 6. Individuals on HD therapy \<3 days per week or \<3 months 7. Currently following a sodium restricted diet approximately \<1,500 mg per day (only excluded from MRI analysis) 8. Currently diagnosed GI disorder or disease or infection

Design outcomes

Primary

MeasureTime frameDescription
Interdialytic weight gain28 daysInterdialytic weight from clinic records
Tissue sodium28 daysMRI detected sodium content in the lower leg (mM)

Secondary

MeasureTime frameDescription
Hydration status28 daysBio-impedance measured total body water, extracellular fluid, intracellular fluid, and calculated fluid volume overload
Cardiovascular function28 daysStandard blood pressure
Biochemical markers28 daysVascular endothelial growth factor-C (VEGF-C), C-reactive protein (CRP), interleukin (IL-6), tumour necrosis factor alpha (TNF-a), endothelial nitric oxide (eNOS), serum sodium (Na)
Gut microbiome (stool sample)28 daysDNA sequencing, bacteria phyla and taxa, stool consistency, gastrointestinal symptoms

Countries

United States

Contacts

Primary ContactLuis M Perez, BS
lmperez2@illinois.edu7192444805
Backup ContactKen Wilund, PhD
kwilund@illinois.edu2172656755

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026