Monocytes in Subjects With Type 1 Diabetes and Chronic Kidney Disease
Recruiting · NCT06694558 · Observational (researchers observe without assigning treatment) · Lead sponsor: The Cleveland Clinic
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed across 1 US state.
- Cleveland Clinic - Cleveland, Ohio, United States