Continuous Glucose Monitoring to Assess Glycemia in Chronic Kidney Disease - Changing Glucose Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Glucose Time in Range
研究概览
简要总结
The goal of this study is to test whether a dipeptidyl peptidase-4 inhibitor, compared with a sulfonylurea, improves time in normal blood glucose range and reduces blood glucose variability. Blood glucose is measured using a continuous glucose monitoring device.
详细描述
This is a proof-of-concept clinical trial testing the effects of linagliptin versus glipizide on glucose variability among people with type 2 diabetes and stage 3-4 CKD. In a cross-over design, each enrolled participant will receive 28 days of each study medication. Study medications will be provided in a randomly assigned order without blinding. The primary study outcome is glucose time in range, measured by blinded continuous glucose monitoring for the last 6 days of each 28-day treatment period. Secondary outcomes include indices of glycemic variability, hypoglycemia, and biomarkers of systemic inflammation, oxidative stress, and albuminuria. The overall goal of this research is to identify safe and effective treatments to control glycemia among patients with diabetes and CKD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •eGFR 15-59 mL/min/1.73 m2
- •Hemoglobin A1c < 8%
- •Age ≥ 18 years
- •Current use of sulfonylurea
排除标准
- •BMI > 40 kg/m2
- •Actively using CGM for clinical care
- •End stage renal disease needing dialysis
- •Kidney transplant
- •Pregnant or nursing
- •Unable to provide informed consent
研究组 & 干预措施
Linagliptin/Glipizide
Arm receives 4 weeks of study drug linagliptin followed by 4 weeks of glipizide
干预措施: Linagliptin (Drug)
Linagliptin/Glipizide
Arm receives 4 weeks of study drug linagliptin followed by 4 weeks of glipizide
干预措施: Glipizide (Drug)
Glipizide/Linagliptin
Arm receives 4 weeks of study drug glipizide followed by 4 weeks linagliptin
干预措施: Linagliptin (Drug)
Glipizide/Linagliptin
Arm receives 4 weeks of study drug glipizide followed by 4 weeks linagliptin
干预措施: Glipizide (Drug)
结局指标
主要结局
Glucose Time in Range
时间窗: last 6 days of each 28-day treatment period
Time with glucose 70-140 mg/dL
次要结局
- Biomarkers of Oxidative Stress(last 6 days of each 28-day treatment period)
- Glycemic Variability(last 6 days of each 28-day treatment period)
- Biomarkers of Systemic Inflammation(last 6 days of each 28-day treatment period)
- Hypoglycemia(last 6 days of each 28-day treatment period)
- Biomarkers of Albuminuria(last 6 days of each 28-day treatment period)
研究者
Ian deBoer
Associate Professor, Medicine/Nephrology
University of Washington