Sodium Glucose Cotransporter-2 Inhibitors and Salt-sensitivity in Type 2 Diabetes (SALT)

August 23, 2023 updated by: Andrea Natali, Azienda Ospedaliero, Universitaria Pisana

Effects of Sodium Glucose Cotransporter-2 Inhibitors on Salt-sensitivity in Patients With Type 2 Diabetes

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • PI
      • Pisa, PI, Italy, 56127
        • Recruiting
        • Azienda Ospedaliero-Universitaria Pisana
        • Contact:
        • Principal Investigator:
          • Andrea Natali, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SGLT2i-treated patients
Behavioral: Hypersodic/Hyposodic diet
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).
Active Comparator: Non SGLT2i-treated patients
Behavioral: Hypersodic/Hyposodic diet
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-hour Blood Pressure
Time Frame: 2 weeks
Systolic and diastolic blood pressure will be measured by 24-h ambulatory blood pressure monitoring
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sodium excretion
Time Frame: 2 weeks
24-hour sodium excretion will be measured by urine collection
2 weeks
Hydration state
Time Frame: 2 weeks
Hydration state with extra- and intracellular water estimation will be measured by bioimpedance
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero, Universitaria Pisana

Collaborators

European Foundation for the Study of Diabetes

Investigators

  • Principal Investigator: Andrea Natali, Azienda Ospedaliero, Universitaria Pisana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

August 18, 2023

First Submitted That Met QC Criteria

August 18, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Actual)

August 24, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SALT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will be shared with other researchers only upon reasonable request to the PI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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