Ignite Creation Date:
2025-12-24 @ 7:03 PM
Ignite Modification Date:
2026-01-01 @ 7:01 AM
Study NCT ID:
NCT06007157
Status:
UNKNOWN
Last Update Posted:
2023-08-24
First Post:
2023-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sodium Glucose Cotransporter-2 Inhibitors and Salt-sensitivity in Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-23', 'studyFirstSubmitDate': '2023-08-18', 'studyFirstSubmitQcDate': '2023-08-18', 'lastUpdatePostDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '24-hour Blood Pressure', 'timeFrame': '2 weeks', 'description': 'Systolic and diastolic blood pressure will be measured by 24-h ambulatory blood pressure monitoring'}], 'secondaryOutcomes': [{'measure': 'Sodium excretion', 'timeFrame': '2 weeks', 'description': '24-hour sodium excretion will be measured by urine collection'}, {'measure': 'Hydration state', 'timeFrame': '2 weeks', 'description': 'Hydration state with extra- and intracellular water estimation will be measured by bioimpedance'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Salt sensitivity', 'Sodium glucose cotransporter 2 inhibitors', 'Type 2 Diabetes', 'Blood Pressure'], 'conditions': ['Blood Pressure', 'Salt; Excess', 'Diabete Type 2']}, 'descriptionModule': {'briefSummary': 'The goal of this interventional study is to test whether sodium-glucose cotransporter 2 inhibitors (SGLT2i) reduce the effects of high dietary sodium intake in patients with type 2 diabetes.\n\nParticipants will undergo a dietary intervention consisting of a week of high-sodium diet, followed by a week of low-sodium diet. At the end of each week the patients will undergo:\n\n* 24-h ambulatory blood pressure measurement;\n* 24-h urine collection;\n* bioimpedance analysis for body composition determination;\n* blood and urine tests.\n\nThe study will compare patients treated with SGLT2i and patients not treated with SGLT2i to test whether the treatment reduces the effects of high sodium intake on blood pressure, body composition and biochemical variables.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-65 years;\n* both males and females;\n* type 2 diabetes.\n\nExclusion Criteria:\n\n* type 1 diabetes;\n* insulin treatment;\n* uncontrolled hypertension (SBP \\> 160 mmHg and/or DBP \\>95 mmHg);\n* pregnancy;\n* other acute or chronic conditions influencing blood pressure and glucose metabolism.'}, 'identificationModule': {'nctId': 'NCT06007157', 'acronym': 'SALT', 'briefTitle': 'Sodium Glucose Cotransporter-2 Inhibitors and Salt-sensitivity in Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero, Universitaria Pisana'}, 'officialTitle': 'Effects of Sodium Glucose Cotransporter-2 Inhibitors on Salt-sensitivity in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'SALT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SGLT2i-treated patients', 'interventionNames': ['Behavioral: Hypersodic/Hyposodic diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non SGLT2i-treated patients', 'interventionNames': ['Behavioral: Hypersodic/Hyposodic diet']}], 'interventions': [{'name': 'Hypersodic/Hyposodic diet', 'type': 'BEHAVIORAL', 'description': 'Participants will undergo a dietary intervention consisting of a week of high-sodium diet (4800 mg/day), followed by a week of low-sodium diet (1200 mg/day).', 'armGroupLabels': ['Non SGLT2i-treated patients', 'SGLT2i-treated patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56127', 'city': 'Pisa', 'state': 'PI', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Andrea Natali, MD', 'role': 'CONTACT', 'email': 'andrea.natali@med.unipi.it', 'phone': '+39050992814'}, {'name': 'Andrea Natali, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliero-Universitaria Pisana', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}], 'centralContacts': [{'name': 'Andrea Natali', 'role': 'CONTACT', 'email': 'andrea.natali@unipi.it', 'phone': '+050992814'}, {'name': 'Martina Chiriacò', 'role': 'CONTACT', 'email': 'martina.chiriaco@spec-med.unipi.it', 'phone': '+050993640'}], 'overallOfficials': [{'name': 'Andrea Natali', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Ospedaliero, Universitaria Pisana'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will be shared with other researchers only upon reasonable request to the PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliero, Universitaria Pisana', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Foundation for the Study of Diabetes', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor of Nutrition', 'investigatorFullName': 'Andrea Natali', 'investigatorAffiliation': 'Azienda Ospedaliero, Universitaria Pisana'}}}}