Is NCT06291155 recruiting in Ann Arbor, MI?

Yes, NCT06291155 is currently recruiting participants at its Ann Arbor, MI location. This type 2 diabetes clinical trial is actively enrolling qualified participants.

How do I join the type 2 diabetes clinical trial in Ann Arbor?

To join this clinical trial in Ann Arbor, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Ann Arbor clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Type 2 Diabetes Clinical Trial in Ann Arbor, MI

About This Type 2 Diabetes Study in Ann Arbor

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

Who Can Participate

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.

Participants must meet the current clinical guidelines for prescribing SGLT2 inhibitors, to maintain FDA-approved standards

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 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.

SGLT2 inhibitors are not recommended during the second or third trimester of pregnancy. Moreover, we do not wish to expose pregnant women to conscious sedation that is used during the kidney biopsies.. Women of childbearing potential must have a negative pregnancy test prior to entry and every 2 months during the study and agree to using an effective form of contraception throughout the study, such as the oral contraceptive pill or an intrauterine device. Women who are planning a pregnancy in the next three years will be excluded.

Known hypersensitivity to canagliflozin or iodine.

Bleeding disorders or requirements for anticoagulation or platelet inhibitors which cannot be safely interrupted since kidney biopsies cannot be performed safely in these individuals.

Massive obesity with body mass index ≥45 kg/m².

Kidney biopsies are more technically difficult with massive obesity.

Allergy to iodine-containing contrast material or shellfish.

Non-diabetic kidney disease - based on clinical history or kidney biopsy examination.

History of osteoporotic fracture.

History of lower-limb amputation irrespective of etiology

Conditions likely to interfere with informed consent or compliance with the protocol.

Known solitary kidney

Size of one or both kidneys on ultrasound \< 9 cm (small kidney size is concerning for renal atrophy due to underlying kidney disease) or \> 2 cm discrepancy between left and right kidney sizes based on largest longitudinal diameter

Current use of UGT enzyme inducters, lithium, and digoxin

Blood urea nitrogen (BUN) \> 80 gm/dL

INR \> 1.4 (a)

PTT \> 35 seconds (a)

Platelet count \< 100,000 uL (a)

Hemoglobin (Hgb) \< 10 mg/dL (a)

Hydronephrosis or other important renal ultrasound findings such as significant stone disease

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Ann Arbor?

Yes, this clinical trial (NCT06291155) has an active research site in Ann Arbor, MI that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Type 2 Diabetes Treatment Options in Ann Arbor, MI

If you're searching for type 2 diabetes treatment options in Ann Arbor, MI, this clinical trial (NCT06291155) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Ann Arbor research site is actively enrolling participants for this clinical trial. You'll receive care from experienced type 2 diabetes specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all type 2 diabetes clinical trials near you to find additional studies recruiting in your area.

Type 2 Diabetes Clinical Trial in Ann Arbor, MI

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