Monocyte responses in adults with type 1 diabetes and chronic kidney disease

Monocytes in Subjects With Type 1 Diabetes and Chronic Kidney Disease

This study will test whether time-in-range changes how monocytes become activated in adults with type 1 diabetes and chronic kidney disease and whether a GLP-1 drug can reduce that activation in lab tests.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: The Cleveland Clinic (Academic / other)
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT06694558 on ClinicalTrials.gov

What this trial studies

This is a cross-sectional study comparing monocyte responses from adults with type 1 diabetes who have CKD to those without CKD. Participants will be stratified by continuous glucose monitor time-in-range (lower <60% vs higher >70%) and provide a blood sample during a single study visit. Monocytes will be studied ex vivo for activation and effects on podocytes, and investigators will test whether a GLP-1 agonist attenuates monocyte activation in laboratory assays. Subjects are recruited from the Cleveland Clinic and the community and may be asked to return for a repeat blood draw if initial samples do not yield enough cells.

Who should consider this trial

Good fit: Ideal candidates are adults 18–65 with type 1 diabetes on insulin and using a continuous glucose monitor, either with CKD (eGFR 60–90 ml/min/1.73 m2 and UACR 30–500 mg/g) or as controls without CKD (eGFR >90 and UACR <30 mg/g).

Not a fit: People already taking GLP-1 agonists, DPP-4 inhibitors, or SGLT2 inhibitors, those with hemoglobin <9 g/dL, those not using a CGM, or individuals outside the 18–65 age range are unlikely to be eligible or to benefit from this protocol.

Why it matters

Potential benefit: If successful, this work could point to time-in-range and GLP-1–related pathways as targets to reduce inflammatory processes that may worsen kidney injury in people with type 1 diabetes.

How similar studies have performed: Prior clinical and laboratory studies have reported anti-inflammatory and kidney-protective effects of GLP-1 drugs in diabetes, but applying ex vivo monocyte activation assays specifically in type 1 diabetes with CKD is relatively novel.

Eligibility criteria

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

Where this trial is running

Cleveland, Ohio

• Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Rong M Zhang, MD — The Cleveland Clinic
• Study coordinator: Andrea Debs

Conditions Chronic Kidney Disease; Type 1 Diabetes