Mechanism of SGLT2 Inhibition in the Kidney
Eligible age
18–80 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: University of Michigan
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ Clinically significant disorders of the liver \[cirrhosis, portal hypertension, hepatitis, increased bilirubin (≥1.5 mg/dl), active or uncontrolled cardiovascular disease, symptomatic peripheral vascular disease, (i.e. intermittent claudication), pulmonary diseases (including uncontrolled asthma and restrictive or obstructive lung disease requiring therapy), renal-urinary disorders (calculi, urinary tract obstruction, glomerulonephritis, chronic infection), gastrointestinal disorders (nausea, vomiting, diarrhea or anorexia sufficient to cause weight loss or wasting), or hematocrit levels ≤30 percent in women or ≤35 percent in men.
- ✕ Prior and ongoing treatment with SGLT2 inhibitors
- ✕ Renovascular or malignant hypertension; uncontrolled hypertension (systolic blood pressure ≥150 or diastolic ≥90 mm Hg)
- ✕ Hematuria of unknown etiology.
- ✕ Prior to entry into the study, any participant with hematuria should be evaluated, the etiology established and documented, and treatment rendered as appropriate.
- ✕ Chronic debilitating disorders with or without treatment (e.g., systemic lupus erythematosus \[SLE\], cancer, amyloidosis, and chronic infection) that would interfere with the assessment of kidney function or that might reduce the chances of survival for a sufficient length of time to evaluate the efficacy of treatment.
- ✕ Currently receiving a drug regimen that includes steroids, immunosuppressants, or investigational new drugs not associated with this trial.
- ✕ Pregnancy.
Where it's recruiting
Ann Arbor
Source: ClinicalTrials.gov · NCT06291155 · last updated 2026-06-11