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Mechanism of SGLT2 Inhibition in the Kidney

NCT06291155 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-10-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

SGLT2 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

Sponsors & Collaborators

  • University of Colorado, Denver

    collaborator OTHER

  • Renal Pre-Competitive Consortium (RPC3)

    collaborator UNKNOWN

  • University of Michigan

    lead OTHER

Principal Investigators

  • Markus Bitzer, MD · Professor of Internal Medicine

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2026-12-31
Completion
2028-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06291155 on ClinicalTrials.gov