Monocytes in Subjects With Type 1 Diabetes and Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
- •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
排除标准
- •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
研究组 & 干预措施
Patients with Type 1 Diabetes
Patients with Type 1 Diabetes with or without chronic kidney disease
结局指标
主要结局
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.
时间窗: monocyte response to varying glycemic exposure after 6 hrs
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
次要结局
- Number of subjects with monocytes which induces higher podocyte injury after monocyte exposure to hyperglycemia compared to euglycemia for 6 hours.(monocyte response to varying glycemic exposure after 6 hrs)