Actively Recruiting
Mechanism of SGLT2 Inhibition in the Kidney
Led by University of Michigan · Updated on 2024-10-03
20
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
Sponsors
U
University of Michigan
Lead Sponsor
U
University of Colorado, Denver
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Mechanism of SGLT2 Inhibition in the Kidney
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18-80 years
- Diagnosed with type 2 diabetes for 3 or more years
- Estimated GFR between 45 and 90 ml/min/1.73m2
- Screening urinary albumin-to-creatinine ratio less than 3000 mg/g
- Willing to participate after study explanation
- On maximum tolerated dose of RAAS inhibitor for at least 3 months if applicable
- On GLP-1 receptor agonist for at least 3 months if applicable
- Meet current clinical guidelines for prescribing SGLT2 inhibitors
You will not qualify if you...
- Significant liver disorders or increased bilirubin (≥1.5 mg/dl)
- Active or uncontrolled cardiovascular disease or symptomatic peripheral vascular disease
- Pulmonary diseases requiring therapy
- Renal-urinary disorders like calculi, obstruction, glomerulonephritis, or chronic infection
- Hematocrit levels ≤30% in women or ≤35% in men
- Prior or ongoing treatment with SGLT2 inhibitors
- Renovascular or malignant hypertension; uncontrolled hypertension (systolic ≥150 or diastolic ≥90 mm Hg)
- Hematuria of unknown cause without evaluation and treatment
- Chronic debilitating disorders interfering with kidney assessment or survival
- Current use of steroids, immunosuppressants, or investigational drugs not related to this study
- Pregnancy or planning pregnancy within 3 years
- Hypersensitivity to canagliflozin or iodine
- Bleeding disorders or anticoagulation that cannot be safely interrupted
- Body mass index ≥45 kg/m2
- Allergy to iodine-containing contrast or shellfish
- Non-diabetic kidney disease
- History of osteoporotic fracture or lower-limb amputation
- Conditions impairing consent or protocol compliance
- Known solitary kidney
- Kidney size <9 cm or >2 cm difference between kidneys on ultrasound
- Use of UGT enzyme inducers, lithium, or digoxin
- Blood urea nitrogen > 80 gm/dL
- INR > 1.4
- PTT > 35 seconds
- Platelet count < 100,000 uL
- Hemoglobin < 10 mg/dL
- Hydronephrosis or significant kidney ultrasound abnormalities (inclusion possible if resolved)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
C
Chrysta C Lienczewski, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here