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Immune cell study may unlock kidney protection in type 1 diabetes

NCT ID NCT06694558

Knowledge-focused Sponsor: The Cleveland Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This study looks at how blood sugar levels affect immune cells (monocytes) and kidney cells in people with type 1 diabetes and early chronic kidney disease. Researchers will compare participants with better versus worse blood sugar control to see if certain immune cells become more active and damage the kidneys. They will also test whether a diabetes drug called GLP-1 agonist can calm these immune cells in a lab dish. The goal is to better understand the link between blood sugar swings and kidney injury.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help explain why some people with type 1 diabetes develop kidney disease and point toward new ways to protect the kidneys.
What could go wrong
This is an observational study that looks at cells in a lab, not a treatment trial. It may not lead to any direct medical changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with Type 1 Diabetes with or without chronic kidney disease.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. T1D CKD subjects: 1. Adults, males or females diagnosed with T1D 2. Age 18-65 years 3. Diagnosed with CKD (eGFR 60-90 ml/min/1.73 m2) 4. Diagnosed with albuminuria (UACR 30-500 mg/g) 5. On insulin injections or pump 6. On CGM Based on baseline CGM metrics, the investigators will stratify subjects to 2 groups Group A (Lower TIR group): TIR\<60%, A1c 7.5-9.5 Group B (Higher TIR group): TIR\>70% A1c 5.0-7.0 2. Controls: T1D subjects without CKD 1. Adults, males or females diagnosed with T1D 2. Age 18-65 years 3. No CKD (eGFR \>90 ml/min/1.73 m2) 4. No albuminuria (UACR \<30 mg/g) 5. On insulin injections or pump 6. On CGM Based on baseline CGM metrics, the investigators will stratify subjects to 2 groups Group A (Lower TIR group): TIR\<60%, A1c 7.5-9.5 Group B (Higher TIR group): TIR\>70% A1c 5.0-7.0 Exclusion Criteria: 1. Hemoglobin \<9 2. On GLP-1 agonist or DPP4 inhibitor or sodium-glucose co-transporter-2 inhibitors use within 30 days 3. pregnancy or plans to become pregnant 4. On steroids 5. Diagnosed with cancer, immunosuppression/autoimmune conditions 6. Reported heavy alcohol use or recreational drug use 7. Any condition which jeopardizes patient safety or affects monocytes at physician's discretion

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic kidney disease (CKD) Type 1 diabetes (T1D)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

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