Sodium Glucose Cotransporter-2 Inhibitors and Salt-sensitivity in Type 2 Diabetes (NCT06007157) | Clinical Trial Compass
UnknownNot Applicable
Sodium Glucose Cotransporter-2 Inhibitors and Salt-sensitivity in Type 2 Diabetes
Italy30 participantsStarted 2023-03-01
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying whether SGLT2 inhibitors affect how my body handles salt and blood pressure over 24 hours — given that I have Type 2 diabetes, is my current blood pressure situation something that makes this kind of research particularly relevant to my care?
2The trial's recruitment status is listed as unknown, so before I get my hopes up, can you help me find out whether this study is still actively enrolling patients or if it has closed?
3Since this is listed as 'Phase NA,' which can mean it's more of a mechanistic or observational study rather than a standard drug trial, can you explain what that means for what I might actually be asked to do, and whether I'd be receiving a new treatment or just being monitored?
4SGLT2 inhibitors like dapagliflozin or empagliflozin are already approved for Type 2 diabetes — so how does participating in a research study around these drugs compare to just starting one as part of my regular treatment plan?
5The trial is measuring 24-hour blood pressure, which likely involves wearing a monitor for a full day — is that kind of commitment realistic for my schedule, and are there other burdens like dietary salt restrictions or multiple clinic visits I should know about before considering this?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.