Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 12:21 AM
NCT ID:
NCT03917758
Eligibility Criteria:
Inclusion Criteria:
* diabetic patients;
* clinical indication to SGLT2i therapy.
Exclusion Criteria:
* signs and symptoms of poor glycemic control (polydipsia, polyuria and weight loss);
* HbA1c \>10% or 86 mmol/mol;
* Body Mass Index (BMI) \> 40 Kg/m2;
* personal history of primary and secondary aldosteronism;
* personal history of heart failure;
* personal history of acute kidney injury;
* personal history of chronic kidney disease;
* personal history of liver cirrhosis;
* personal history of protein-wasting syndrome;
* personal history of renin secreting tumor;
* personal history of diabetes insipidus;
* personal history of syndrome of inappropriate antidiuresis (SIAD);
* personal history of hypocortisolism and hypercortisolism;
* therapy with Angiotensin Converting Enzyme inhibitors;
* therapy with Angiotensin Receptor Blockers;
* therapy with renin inhibitors;
* therapy with beta-blockers;
* therapy with alfa2-receptors agonists;
* therapy with Calcium Channel Blockers;
* therapy with diuretics;
* therapy with mineralocorticoid receptor antagonists;
* therapy with non steroidal and steroidal anti-inflammatory drugs.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03917758
Study Brief:
Protocol Section:
NCT03917758