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Monocytes in Subjects With Type 1 Diabetes and Chronic Kidney Disease
NCT06694558 · The Cleveland Clinic
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
The monocyte response from patients with T1D CKD will be compared to monocytes from T1D subjects without CKD as a control. Potential subjects will be recruited from existing Cleveland Clinic patients or the community. The study will entail an initial phone screen followed by a formal screening visit to determine eligibility. Eligible subjects will return for a study visit within 4 weeks for a blood draw. There is no intervention. This will complete the study for subjects unless the investigators do not obtain enough monocytes from the initial blood draw to complete the requisite lab studies. If this occurs, the investigators will ask the patient to return for a repeat study visit. All endpoints evaluating monocyte and podocyte injury will be conducted in the lab ex vivo.
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
Study design
Enrollment target: 60 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-03-01
Estimated completion: 2026-07-01
Last updated: 2025-06-11
Primary outcomes
- • Number of subjects with proinflammatory monocytes by flow cytometry, higher ER stress, and cytokine levels after monocyte exposure to hyperglycemia compared to euglycemia for 6 hours. (monocyte response to varying glycemic exposure after 6 hrs)
Sponsor
The Cleveland Clinic · other
With: Stanford University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contacts & investigators
ContactAndrea Debs · contact · debsa@ccf.org · 216-445-8354
InvestigatorRong M Zhang, MD · principal_investigator, The Cleveland Clinic
All locations (1)
Cleveland ClinicRecruiting
Cleveland, Ohio, United States