Kidney Failure, Chronic Clinical Trial
Official title:
Dietary Sodium (DS) Intervention to Reduce Volume Overload and 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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03246984 -
VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ
|
N/A | |
| Completed |
NCT02922361 -
Spending and Outcomes for Complex Medicare Advantage Patients
|
||
| Completed |
NCT02235571 -
iChoose Decision Kidney Aid for End-Stage Renal Disease Patients
|
N/A | |
| Completed |
NCT01933789 -
Improving Communication About Serious Illness
|
N/A | |
| Completed |
NCT01922843 -
A Phase 2 Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis
|
Phase 2 | |
| Completed |
NCT01930396 -
Use of Tinzaparin for Anticoagulation in Hemodialysis
|
Phase 4 | |
| Not yet recruiting |
NCT01674660 -
Factors Associated With Interdialytic Blood Pressure Variability in Maintenance Hemodialysis Patients
|
N/A | |
| Not yet recruiting |
NCT01157260 -
The Effects of AST-120 on Endothelial Dysfunction in Patients With Chronic Kidney Disease
|
Phase 4 | |
| Completed |
NCT01209403 -
Insulin-like Growth Factor (IGF-I) in Hemodialysis Patients
|
Phase 4 | |
| Completed |
NCT00753116 -
Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension
|
Phase 1 | |
| Recruiting |
NCT00532688 -
N-Acetylcysteine in Heart Failure With Coexistent Chronic Renal Failure
|
Phase 2/Phase 3 | |
| Completed |
NCT00534144 -
Comparison Between Effects of Two Iron Preparations on Protein in the Urine
|
Phase 1 | |
| Completed |
NCT00528788 -
How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis
|
Phase 4 | |
| Completed |
NCT00226902 -
Vascular Reactivity in Kidney Disease Patients
|
N/A | |
| Completed |
NCT00382044 -
Audit of the Effect of Changing From IV to SC Administration of ESA's in Haemodialysis Patients
|
N/A | |
| Recruiting |
NCT00235287 -
Pulse Wave Velocity, Pulse Wave Morphology and Blocking of the Reninangiotensin System in Patients With Chronic Kidney Disease
|
Phase 4 | |
| Completed |
NCT00224081 -
DRIVE Trial (Dialysis Patients' Response to Intravenous [IV] Iron With Elevated Ferritin)
|
Phase 4 | |
| Completed |
NCT00071214 -
Study to Evaluate the Effectiveness of StaphVAX in Adults on Hemodialysis
|
Phase 3 | |
| Completed |
NCT00049907 -
Cardiac and Renal Disease Study (CARDS)
|
N/A | |
| Completed |
NCT00006297 -
Risk Factors for CV Disease in a Dialysis Cohort
|
N/A |