ACTRN12621000152820尚未招募4 期
A randomised crossover study examining the effects of sodium restriction on 24-hour ambulatory blood pressure in people with type 2 diabetes and chronic kidney disease treated with empagliflozin
St Vincent's Hospital0 个研究点目标入组 30 人开始时间: 2021年2月15日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Age range: 18 - 75 years
- •- Diagnosis of type 2 diabetes and HbA1c up to 10%
- •- Stage 2, 3 or 4 CKD (eGFR 60-89 mL/min/1.73 m2 and urine albumin-to-creatinine ratio >30 mg/g, eGFR 30-59 mL/min/1.73m2 or 15 – 29 mL/min/1.73m2, respectively) at the time of screening, and stable renal function defined as a difference of <30% between two consecutive eGFR in the 3 months before the screening visit
- •- On stable anti-hypertensive dose of an angiotensin-converting-enzyme (ACE) inhibitor or angiotensin-receptor blocker (ARB) in the one month before the screening visit
- •- Willing to give written informed consent and willingness to participate to and comply with the study
排除标准
- •- Symptomatic hypotension, systolic blood pressure less than 110 mmHg or hypertension – systolic blood pressure greater than 170 mmHg
- •- Liver disease (alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase (ALP) greater than 3-times normal range limit)
- •- On haemodialysis or peritoneal dialysis
- •- Serum potassium of greater than or equal to 6.0 mmol/L
- •- Type 1 diabetes, diabetes secondary to pancreatic disease, history of diabetic ketoacidosis
- •- History of neoplastic disease (except for basal cell carcinoma) in the previous 1 year.
- •- History of recurrent urinary tract infections, genital infections and/or urogenital structural abnormalities
- •- Overt nephrotic syndrome
- •- Acute coronary syndrome, stroke, transient ischaemic attack, or other cardiovascular event within 3 months of screening
- •- Use of the following medications: current treatment with a SGLT2 inhibitor, current or recent (within 3 months) treatment with a glucagon-like peptide-1 (GLP1) agonist, treatment with a glucocorticoid, treatment with a non-steroidal anti-inflammatory drug (at least weekly), investigational new drug within the last 3 months
- •- Previous bariatric surgery
- •- Uncontrolled endocrine disorder except type 2 diabetes mellitus
- •- Current smoker
- •- Alcohol intake greater than or equal to 14 standard drinks per week
- •- Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study
- •- History of a psychological illness or condition such as to interfere with a person’s ability to understand the requirements of the study.
研究者
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