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Monocytes in Subjects With Type 1 Diabetes and Chronic Kidney Disease

RECRUITINGSponsored by The Cleveland Clinic
Actively Recruiting
SponsorThe Cleveland Clinic
Started2025-03-01
Est. completion2025-12-30
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
Locations1 site

Summary

This is a cross-sectional study in patients with Type 1 diabetes (TID) and chronic kidney disease (CKD) to test if time in range (TIR) affects the degree of hyperglycemia required for monocyte activation, podocyte injury, and assess if monocyte activation is attenuated by glucagon-like peptide (GLP-1) agonist treatment ex vivo.

Eligibility

Age: 18 Years – 65 YearsHealthy volunteers accepted
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

Conditions3

Chronic Kidney Disease(CKD)DiabetesType 1 Diabetes (T1D)

Locations1 site

Cleveland Clinic
Cleveland, Ohio, 44195
Andrea Debs216-445-8354debsa@ccf.org

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