Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-01-13 @ 7:47 AM
Study NCT ID:
NCT03189758
Status:
UNKNOWN
Last Update Posted:
2020-08-03
First Post:
2017-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Sodium (DS) Intervention to Reduce Volume Overload and Tissue Sodium in Magnetic Resonance Imaging (MRI) for Hemodialysis (HD) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Observational control followed by dietary intervention'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-30', 'studyFirstSubmitDate': '2017-06-14', 'studyFirstSubmitQcDate': '2017-06-14', 'lastUpdatePostDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interdialytic weight gain', 'timeFrame': '28 days', 'description': 'Interdialytic weight from clinic records'}, {'measure': 'Tissue sodium', 'timeFrame': '28 days', 'description': 'MRI detected sodium content in the lower leg (mM)'}], 'secondaryOutcomes': [{'measure': 'Hydration status', 'timeFrame': '28 days', 'description': 'Bio-impedance measured total body water, extracellular fluid, intracellular fluid, and calculated fluid volume overload'}, {'measure': 'Cardiovascular function', 'timeFrame': '28 days', 'description': 'Standard blood pressure'}, {'measure': 'Biochemical markers', 'timeFrame': '28 days', 'description': '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)'}, {'measure': 'Gut microbiome (stool sample)', 'timeFrame': '28 days', 'description': 'DNA sequencing, bacteria phyla and taxa, stool consistency, gastrointestinal symptoms'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic kidney disease', 'hemodialysis', 'sodium restriction', 'MRI'], 'conditions': ['Kidney Failure, Chronic', 'Dietary Modification']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.\n\nThe 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.\n\nThe 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willingness to sign informed consent document and age 18 or greater.\n* Willingness to consume intervention meals 3 times per day (with provided snacks) for 30 days.\n\nExclusion Criteria:\n\n1. Individuals with pacemakers (exclusion from cardiovascular testing only)\n2. Individuals with major amputations (i.e. whole limb: foot, ankle, leg, arm)\n3. Individuals with ferric metal implants or devices in the body (excluded from MRI testing only)\n4. Claustrophobic individuals (excluded from MRI testing only)\n5. Individuals that do not otherwise meet MRI screening requirements (mentioned below, excluded from MRI testing only)\n6. Individuals on HD therapy \\<3 days per week or \\<3 months\n7. Currently following a sodium restricted diet approximately \\<1,500 mg per day (only excluded from MRI analysis)\n8. Currently diagnosed GI disorder or disease or infection'}, 'identificationModule': {'nctId': 'NCT03189758', 'acronym': 'DSMRI', 'briefTitle': 'Dietary Sodium (DS) Intervention to Reduce Volume Overload and Tissue Sodium in Magnetic Resonance Imaging (MRI) for Hemodialysis (HD) Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Urbana-Champaign'}, 'officialTitle': 'Dietary Sodium (DS) Intervention to Reduce Volume Overload and Tissue Sodium in Magnetic Resonance Imaging (MRI) for Hemodialysis (HD) Patients', 'orgStudyIdInfo': {'id': '17530'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Participants will follow a Observational Control Diet (CON) diet followed by an Controlled Dietary Sodium Restriction (INT) diet.', 'interventionNames': ['Other: Observational Control Diet', 'Other: Controlled Dietary Sodium Restriction']}], 'interventions': [{'name': 'Observational Control Diet', 'type': 'OTHER', 'otherNames': ['CON'], 'description': 'Participants will follow their usual or normal diet for 30 days (days 1-30) while under study observation.', 'armGroupLabels': ['Intervention']}, {'name': 'Controlled Dietary Sodium Restriction', 'type': 'OTHER', 'otherNames': ['INT'], 'description': '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', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61801', 'city': 'Urbana', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ken Wilund, PhD', 'role': 'CONTACT', 'email': 'kwilund@illinois.edu', 'phone': '217-265-6755'}, {'name': 'Ken Wilund, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Illinois at Urbana-Champaign', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}], 'centralContacts': [{'name': 'Luis M Perez, BS', 'role': 'CONTACT', 'email': 'lmperez2@illinois.edu', 'phone': '7192444805'}, {'name': 'Ken Wilund, PhD', 'role': 'CONTACT', 'email': 'kwilund@illinois.edu', 'phone': '2172656755'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Urbana-Champaign', 'class': 'OTHER'}, 'collaborators': [{'name': 'Renal Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}