RecruitingNCT06694558

Monocytes in Subjects With Type 1 Diabetes and Chronic Kidney Disease

Sponsor

The Cleveland Clinic

Enrollment

60 participants

Start Date

Mar 1, 2025

Study Type

OBSERVATIONAL

Conditions

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

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria16

T1D CKD subjects:
Adults, males or females diagnosed with T1D
Age 18-65 years
Diagnosed with CKD (eGFR 60-90 ml/min/1.73 m2)
Diagnosed with albuminuria (UACR 30-500 mg/g)
On insulin injections or pump
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
Controls: T1D subjects without CKD
Adults, males or females diagnosed with T1D
Age 18-65 years
No CKD (eGFR \>90 ml/min/1.73 m2)
No albuminuria (UACR \<30 mg/g)
On insulin injections or pump
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 Criteria7

Hemoglobin \<9
On GLP-1 agonist or DPP4 inhibitor or sodium-glucose co-transporter-2 inhibitors use within 30 days
pregnancy or plans to become pregnant
On steroids
Diagnosed with cancer, immunosuppression/autoimmune conditions
Reported heavy alcohol use or recreational drug use
Any condition which jeopardizes patient safety or affects monocytes at physician's discretion

Locations(1)

Cleveland Clinic

Cleveland, Ohio, United States

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