NCT05507892 Renal Mechanism of SGLT2 Inhibition
| NCT ID | NCT05507892 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Colorado, Denver |
| Condition | Type 2 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-10-10 |
| Primary Completion | 2026-12-15 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
Canagliflozin is an oral drug which is currently approved for use in patients with type 2 diabetes by the US Food and Drug Administration (FDA). Canagliflozin acts by increasing salt and sugar loss in the urine, and has shown to protect heart, kidney, and blood vessel function in patients with type 2 diabetes. However, it is unknown how canagliflozin protects the kidneys from disease. Therefore, this study plans to learn more about how canagliflozin works to protect against diabetic kidney disease in adults with type 2 diabetes. This study will use state-of-the-art kidney imaging, kidney biopsies and detailed testing of kidney function to determine the mechanisms of protection afforded by canagliflozin.
Eligibility Criteria
Inclusion Criteria: * Aged 18-80 years. The lower age limit was set so renal function test results would not reflect changes associated with growth. * Diagnosis of type 2 diabetes for ≥ 3 years. * Estimated GFR \>45 and \< 90 ml/min/1.73m2 as determined from the CKD-EPI equation using serum creatinine (Levey et al., 2009). * A screening urinary albumin-to-creatinine ratio \<3000 mg/g. * Willingness to participate after receiving a thorough explanation of the study. * Participants receiving a RAAS inhibitor must have been receiving the drug at maximum tolerable dose for at least 3 months prior to the study baseline examination. * Participants receiving a GLP-1 receptor agonist must have been receiving the drug for at least 3 months prior to the study baseline examination. Exclusion Criteria: * Clinically significant disorders of the liver \[cirrhosis, portal hypertension, hepatitis, increased bilirubin (≥1.5 mg/dl), active or uncontrolled cardiovascular disease, symptomatic peripheral v
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.