Sodium-glucose Transporter 2 Inhibitor Use in Pre-diabetes: Initial Evaluation in Veterans
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Recruitment
研究概览
简要总结
Prediabetes effects 96 million people 18 years of age or older. It is important to identify treatment options to slow or prevent progression to diabetes. It is also critical to assess the potential of medications like sodium glucose transporter 2 inhibitors to reduce the risk of cardiovascular events and kidney complications, both common and costly complications of diabetes. This is a 12-week, open-label pilot feasibility study assessing the use of empagliflozin in prediabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of prediabetes defined by HbA1c >5.7% and <6.5% or fasting glucose 100-125 mg/dL with documentation of diagnosis (ICD-10 code) within electronic health record at time of enrollment
- •Age 35 to 60 years at time of enrollment
- •Able to read and speak English
排除标准
- •Diagnosis of diabetes (type 2 or type 1)
- •Contraindication to SGLT2i medication per medication labeling, prior adverse reaction to SGLT2i medication, or received SGLT2i medication within the 6 months prior to enrollment
- •Currently prescribed an antihyperglycemic agent approved for treatment of type 2 diabetes or taking any FDA-approved weight loss agent or over-the-counter supplement promoted for weight loss
- •Veterans unable to complete informed consent process (Veterans with impaired decision-making ability or who require use of a legally authorized representative)
- •Women who are pregnant or may become pregnant
- •Veterans with neurogenic bladder, indwelling catheter, or urinary tract infection within the previous 12 months requiring hospitalization or emergency department visit
研究组 & 干预措施
Standard Care
Participants in this arm will receive lifestyle education to manage pre-diabetes as well as the monitoring of HbA1c, kidney function, weight, and blood pressure.
干预措施: Lifestyle education (Other)
Standard Care plus empagliflozin
Participants in this arm will receive lifestyle education to manage pre-diabetes as well as the monitoring of HbA1c, kidney function, weight, and blood pressure. They will also receive empagliflozin 10mg daily.
干预措施: Empagliflozin 10mg daily (Drug)
Standard Care plus empagliflozin
Participants in this arm will receive lifestyle education to manage pre-diabetes as well as the monitoring of HbA1c, kidney function, weight, and blood pressure. They will also receive empagliflozin 10mg daily.
干预措施: Lifestyle education (Other)
结局指标
主要结局
Recruitment
时间窗: 12 weeks
Number of participants screened during study period Number of participants randomized during study period Number of participants enrolled during study period
Retention
时间窗: 12 weeks
Number of participants enrolled who complete the study Number of participants enrolled who do not complete the study and reason for not completing the study
次要结局
- HbA1c (%)(12 weeks)
- Renal function (ml/min)(Every visit (baseline (T), T+2-4 weeks, T+12 weeks))
- Weight (kg)(Every visit (baseline (T), T+2-4 weeks, T+12 weeks))
- Blood pressure (mmHg)(Every visit (baseline (T), T+2-4 weeks, T+12 weeks))
- Adverse Events(12 weeks)
研究者
Beth Greck
Principal Investigator
Charles George VA Medical Center