Dietary Sodium (DS) Intervention to Reduce Tissue Sodium in Hemodialysis (HD) Patients (DSMRI)
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|ClinicalTrials.gov Identifier: NCT03189758|
Recruitment Status : Recruiting
First Posted : June 16, 2017
Last Update Posted : August 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Kidney Failure, Chronic Dietary Modification||Other: Observational Control Diet Other: Controlled Dietary Sodium Restriction||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Observational control followed by dietary intervention|
|Masking:||None (Open Label)|
|Official Title:||Dietary Sodium (DS) Intervention to Reduce Tissue Sodium in Magnetic Resonance Imaging (MRI) for Hemodialysis (HD) Patients|
|Actual Study Start Date :||June 19, 2017|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2020|
Participants will follow a Observational Control Diet (CON) diet followed by an Controlled Dietary Sodium Restriction (INT) diet.
Other: Observational Control Diet
Participants will follow their usual or normal diet for 30 days (days 1-30) while under study observation.
Other Name: CON
Other: Controlled Dietary Sodium Restriction
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
Other Name: INT
- Tissue sodium [ Time Frame: 30 days ]MRI detected sodium content in the lower leg (mM)
- Hydration status [ Time Frame: 30 days ]Bio-impedance measured total body water, extracellular fluid, intracellular fluid, and calculated fluid volume overload
- Cardiovascular function [ Time Frame: 30 days ]Bio-impedance measured stroke volume and derived components, standard blood pressure, central pulse wave velocity
- Biochemical markers [ Time Frame: 30 days ]Vascular 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) [ Time Frame: 30 days ]DNA sequencing, bacteria phyla and taxa, stool consistency, gastrointestinal symptoms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03189758
|Contact: Luis M Perez, BSemail@example.com|
|Contact: Ken Wilund, PhDfirstname.lastname@example.org|
|United States, Illinois|
|University of Illinois at Urbana-Champaign||Recruiting|
|Urbana, Illinois, United States, 61801|
|Contact: Ken Wilund, PhD 217-265-6755 email@example.com|
|Principal Investigator: Ken Wilund, PhD|