Monocytes in Subjects With Type 1 Diabetes and Chronic Kidney Disease

Launched by THE CLEVELAND CLINIC · Nov 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how well blood sugar levels, specifically the time patients spend in a healthy range, affect certain immune cells known as monocytes in people with Type 1 diabetes (T1D) and chronic kidney disease (CKD). The researchers want to see if high blood sugar levels lead to problems in the kidneys and if treatment with a specific medication, called a GLP-1 agonist, can help reduce these issues.

To participate in this study, you need to be an adult between the ages of 18 and 65 with T1D and CKD, or a T1D patient without CKD serving as a control. Participants will be divided into two groups based on their blood sugar levels. If you join, you can expect to undergo evaluations to assess your blood sugar control and its effects on your health. The trial is currently not recruiting participants, so it’s important to check back for updates if you’re interested.

Gender

ALL

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