Monocytes in Subjects With Type 1 Diabetes and Chronic Kidney Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Disease(CKD), Type 1 Diabetes (T1D). Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Primary outcome measures
- 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. [Time frame: monocyte response to varying glycemic exposure after 6 hrs]
Secondary outcome measures (1)
- Number of subjects with monocytes which induces higher podocyte injury after monocyte exposure to hyperglycemia compared to euglycemia for 6 hours. [Time frame: monocyte response to varying glycemic exposure after 6 hrs]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 1 center
- Cleveland Clinic — Cleveland
Identifiers
NCT: NCT06694558 · 24-1015 · K12DK133995