Multidisciplinary Dissection of Renal and Metabolic Effects of Glyfozines on Elderly Patients: From Molecular Aspects to Clinical Indications
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Patient health status prior and after 6 months of SGLT2i therapy through Frailty Index variation (FI)
研究概览
简要总结
The project aims to study the impact of SGLT2i therapy on clinical and biochemical aspects. in elderly. The project will combine different types of data, such as clinical and biological information, and will use advanced Bayesian statistical methods to understand the relationship between risk factors and patient outcomes following treatment with SGLT2 inhibitors.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is willing and able to give informed consent for participation in the study;
- •Patients must be enrolled also in MED-Cli e MED-Mol studies by signing both the MED-Cli e MED-Mol informed consents.
- •The medical product is the standard of care for the patient and has been prescribed according to clinical practice and independent of the present study;
- •Age ≥65 years;
- •Participant has not yet started the prescribed SGLT2i therapy;
- •Participant has at least one clinical indication for SGLT2i use according to clinical practice guidelines.
排除标准
- •Current or previous use of SGLT2i;
- •Inability to sign the informed consent.
结局指标
主要结局
Patient health status prior and after 6 months of SGLT2i therapy through Frailty Index variation (FI)
时间窗: From enrollment to 6 months
Patient health status prior and after 6 months of SGLT2i therapy through Frailty Index variation (FI). The FI is score measured by comparing the ratio of health deficits present within an individual to possible health deficits, using a pre-specified list of 30 or more deficits. Deficits included in the model will be collected during the visit trough questionnaires and clinical and biochemical evaluation
次要结局
未报告次要终点
研究者
Chiara Lanzani
Professor
Ospedale San Raffaele