Back to resultsSodium Glucose Cotransporter-2 Inhibitors and Salt-sensitivity in Type 2 Diabetes (SALT)
Primary Purpose
Blood Pressure, Salt; Excess, Diabete Type 2
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Hypersodic/Hyposodic diet
Sponsored by
About this trial
This is an interventional treatment trial for Blood Pressure focused on measuring Salt sensitivity, Sodium glucose cotransporter 2 inhibitors, Type 2 Diabetes, Blood Pressure
Eligibility Criteria
Inclusion Criteria: age 18-65 years; both males and females; type 2 diabetes. Exclusion Criteria: type 1 diabetes; insulin treatment; uncontrolled hypertension (SBP > 160 mmHg and/or DBP >95 mmHg); pregnancy; other acute or chronic conditions influencing blood pressure and glucose metabolism.
Sites / Locations
- Azienda Ospedaliero-Universitaria PisanaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SGLT2i-treated patients
Non SGLT2i-treated patients
Arm Description
Outcomes
Primary Outcome Measures
24-hour Blood Pressure
Systolic and diastolic blood pressure will be measured by 24-h ambulatory blood pressure monitoring
Secondary Outcome Measures
Sodium excretion
24-hour sodium excretion will be measured by urine collection
Hydration state
Hydration state with extra- and intracellular water estimation will be measured by bioimpedance
Full Information
NCT ID
NCT06007157
First Posted
August 18, 2023
Last Updated
August 23, 2023
Sponsor
Azienda Ospedaliero, Universitaria Pisana
Collaborators
European Foundation for the Study of Diabetes
1. Study Identification
Unique Protocol Identification Number
NCT06007157
Brief Title
Sodium Glucose Cotransporter-2 Inhibitors and Salt-sensitivity in Type 2 Diabetes
Acronym
SALT
Official Title
Effects of Sodium Glucose Cotransporter-2 Inhibitors on Salt-sensitivity in Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero, Universitaria Pisana
Collaborators
European Foundation for the Study of Diabetes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Participants 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:
24-h ambulatory blood pressure measurement;
24-h urine collection;
bioimpedance analysis for body composition determination;
blood and urine tests.
The 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Salt; Excess, Diabete Type 2
Keywords
Salt sensitivity, Sodium glucose cotransporter 2 inhibitors, Type 2 Diabetes, Blood Pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SGLT2i-treated patients
Arm Type
Experimental
Arm Title
Non SGLT2i-treated patients
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Hypersodic/Hyposodic diet
Intervention 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).
Primary Outcome Measure Information:
Title
24-hour Blood Pressure
Description
Systolic and diastolic blood pressure will be measured by 24-h ambulatory blood pressure monitoring
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Sodium excretion
Description
24-hour sodium excretion will be measured by urine collection
Time Frame
2 weeks
Title
Hydration state
Description
Hydration state with extra- and intracellular water estimation will be measured by bioimpedance
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 18-65 years;
both males and females;
type 2 diabetes.
Exclusion Criteria:
type 1 diabetes;
insulin treatment;
uncontrolled hypertension (SBP > 160 mmHg and/or DBP >95 mmHg);
pregnancy;
other acute or chronic conditions influencing blood pressure and glucose metabolism.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Natali
Phone
+050992814
Email
andrea.natali@unipi.it
First Name & Middle Initial & Last Name or Official Title & Degree
Martina Chiriacò
Phone
+050993640
Email
martina.chiriaco@spec-med.unipi.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Natali
Organizational Affiliation
Azienda Ospedaliero, Universitaria Pisana
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliero-Universitaria Pisana
City
Pisa
State/Province
PI
ZIP/Postal Code
56127
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Natali, MD
Phone
+39050992814
Email
andrea.natali@med.unipi.it
First Name & Middle Initial & Last Name & Degree
Andrea Natali, Professor
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will be shared with other researchers only upon reasonable request to the PI
Learn more about this trial
Sodium Glucose Cotransporter-2 Inhibitors and Salt-sensitivity in Type 2 Diabetes
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