RecruitingPhase 4NCT06291155

Mechanism of SGLT2 Inhibition in the Kidney

Molecular Mechanisms of SGLT2 Inhibition in Diabetic Kidney Disease


Sponsor

University of Michigan

Enrollment

20 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this open-label, non-randomized clinical trial is to determine what effects, if any, an FDA-approved drug class known as SGLT2 inhibitors (Canagliflozin or INVOKANA) has any protective effects on kidney function in Type 2 diabetes. We are looking for participants 18-80 years of age, who have had a clinical diagnosis of Type 2 diabetes for ≥ 3 years. Participants will be asked to sign a consent and complete a screening visit prior to study entry including the following procedures for this study: Consent and Screening: * Laboratory tests to determine baseline health * Ultrasound to measure kidney size and ensure presence of 2 functioning kidneys Month 0: * Study entry kidney MRI (day 0) * Study entry kidney biopsy (within 30 days of MRI) * Study entry visit for dispensing 100 mg/daily Canagliflozin medication 3 month supply Month 3: * Study visit to dispense remaining 3 months of 100 mg/daily Canagliflozin medication * Review of systems Month 6: * Follow-up kidney MRI * Follow-up kidney biopsy Study participants will also be requested to provide blood and urine samples for biobanking purposes. They will also be provided the opportunity to provide a stool sample at two time points, as well as the option to participate in a related study collecting samples to create induced Pluripotent Stem Cells (iPSCs). Participants will be compensated for their time and loss of work time, additionally, a nominal additional compensation for optional stool and iPSC samples.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how a class of diabetes medications called SGLT2 inhibitors (such as empagliflozin or dapagliflozin) protect the kidneys in people with type 2 diabetes and mild-to-moderate kidney disease. Researchers want to understand the exact mechanism so these drugs can be used more effectively. **You may be eligible if...** - You are between 18 and 80 years old - You have had type 2 diabetes for at least 3 years - Your kidney function is mildly to moderately reduced (eGFR between 45 and 90) - Your urine protein levels are not extremely high - If you take blood pressure medications for the kidneys (RAAS inhibitors) or GLP-1 medications, you have been on a stable dose for at least 3 months **You may NOT be eligible if...** - You have type 1 diabetes - Your kidney function is severely reduced (eGFR below 45) - You are pregnant or plan to become pregnant - You have other significant kidney or medical conditions that could affect the study results Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSGLT2 inhibitor

All participants will be receive 100 mg/daily doses of Canagliflozin (INVOKANA) for 6 months. Canagliflozin is a Sodium-glucose cotransporter 2 (SGLT2) inhibitor


Locations(1)

University of Michigan

Ann Arbor, Michigan, United States

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NCT06291155


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