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Trial record 46 of 55 for:    cancer AND energy restriction

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
Sponsor:
Collaborator:
Renal Research Institute
Information provided by (Responsible Party):
University of Illinois at Urbana-Champaign

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.

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Dietary Modification Other: Observational Control Diet Other: Controlled Dietary Sodium Restriction Not Applicable

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.


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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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Sodium

Arm Intervention/treatment
Experimental: Intervention
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




Primary Outcome Measures :
  1. Tissue sodium [ Time Frame: 30 days ]
    MRI detected sodium content in the lower leg (mM)


Secondary Outcome Measures :
  1. Hydration status [ Time Frame: 30 days ]
    Bio-impedance measured total body water, extracellular fluid, intracellular fluid, and calculated fluid volume overload

  2. Cardiovascular function [ Time Frame: 30 days ]
    Bio-impedance measured stroke volume and derived components, standard blood pressure, central pulse wave velocity

  3. 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)

  4. Gut microbiome (stool sample) [ Time Frame: 30 days ]
    DNA sequencing, bacteria phyla and taxa, stool consistency, gastrointestinal symptoms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Luis M Perez, BS 7192444805 lmperez2@illinois.edu
Contact: Ken Wilund, PhD 2172656755 kwilund@illinois.edu

Locations
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United States, Illinois
University of Illinois at Urbana-Champaign Recruiting
Urbana, Illinois, United States, 61801
Contact: Ken Wilund, PhD    217-265-6755    kwilund@illinois.edu   
Principal Investigator: Ken Wilund, PhD         
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
Renal Research Institute

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Responsible Party: University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT03189758     History of Changes
Other Study ID Numbers: 17530
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of Illinois at Urbana-Champaign:
chronic kidney disease
hemodialysis
sodium restriction
MRI

Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic