Testing the effects of SGLT2 inhibitors on salt sensitivity in type 2 diabetes
Effects of Sodium Glucose Cotransporter-2 Inhibitors on Salt-sensitivity in Patients With Type 2 Diabetes
This study is testing if a diabetes medication can help people with type 2 diabetes handle high salt diets better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Azienda Ospedaliero, Universitaria Pisana Academic / other |
| Locations | 1 site (Pisa, PI) |
| Trial ID | NCT06007157 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate whether sodium-glucose cotransporter 2 inhibitors (SGLT2i) can mitigate the impact of high dietary sodium intake on patients with type 2 diabetes. Participants will follow a dietary regimen alternating between high-sodium and low-sodium weeks, during which various health metrics will be assessed, including blood pressure, body composition, and biochemical markers. The study will compare outcomes between those treated with SGLT2i and those who are not, to determine the effectiveness of the treatment in managing salt sensitivity.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 with type 2 diabetes.
Not a fit: Patients with type 1 diabetes, those on insulin treatment, or individuals with uncontrolled hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of blood pressure and overall health for patients with type 2 diabetes who are sensitive to dietary sodium.
How similar studies have performed: While the specific approach of this study may be novel, previous studies have indicated potential benefits of SGLT2 inhibitors in managing blood pressure in diabetic patients.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Pisa, PI
- Azienda Ospedaliero-Universitaria Pisana — Pisa, Pi, Italy (Recruiting)
Study contacts
- Principal investigator: Andrea Natali — Azienda Ospedaliero, Universitaria Pisana
- Study coordinator: Andrea Natali
- Email: andrea.natali@unipi.it
- Phone: +050992814
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.