Effects of Sodium Glucose Cotransporter-2 Inhibitors on Salt-sensitivity in Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- 24-hour Blood Pressure
研究概览
简要总结
The goal of this interventional study is to test whether sodium-glucose cotransporter 2 inhibitors (SGLT2i) reduce the effects of high dietary sodium intake in patients with type 2 diabetes.
Participants will undergo a dietary intervention consisting of a week of high-sodium diet, followed by a week of low-sodium diet. At the end of each week the patients will undergo:
- 24-h ambulatory blood pressure measurement;
- 24-h urine collection;
- bioimpedance analysis for body composition determination;
- blood and urine tests.
The study will compare patients treated with SGLT2i and patients not treated with SGLT2i to test whether the treatment reduces the effects of high sodium intake on blood pressure, body composition and biochemical variables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-65 years;
- •both males and females;
- •type 2 diabetes.
排除标准
- •type 1 diabetes;
- •insulin treatment;
- •uncontrolled hypertension (SBP > 160 mmHg and/or DBP >95 mmHg);
- •pregnancy;
- •other acute or chronic conditions influencing blood pressure and glucose metabolism.
结局指标
主要结局
24-hour Blood Pressure
时间窗: 2 weeks
Systolic and diastolic blood pressure will be measured by 24-h ambulatory blood pressure monitoring
次要结局
- Sodium excretion(2 weeks)
- Hydration state(2 weeks)
研究者
Andrea Natali
Full Professor of Nutrition
Azienda Ospedaliero, Universitaria Pisana