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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Rong M Zhang, MD — The Cleveland Clinic
• Study coordinator: Andrea Debs
• Email: debsa@ccf.org
• Phone: 216-445-8354

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.