NL-OMON55197招募中不适用
The role of glycosaminoglycans and macrophages in salt-sensitivity of blood pressure - SALT-3
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •All subjects:
- •- Men and women Between 18 and 75 years of age
- •- Office blood pressure <= 140/90 mmHg
- •- A body mass index <= 30 kg/m2
- •- Capable of giving written informed consent and able to comply with the
- •requirements and restrictions listed in the informed consent form
- •Microalbuminuric type 2 diabetes patients:
- •- Known with Diabetes Mellitus type 2
- •- Either albuminuria (20-200 mg/L in a morning urine sample / 30-300 mg/24 hrs)
- •- Stable renal function (eGFR 45-90 ml/min/1.73m2) with or without on stable
- •therapy with RAAS inhibiting agents
- •- HbA1c levels below 10.0% (86mmol/mol) during the 6 months preceding the study
- •Nondiabetic CKD patients
- •- Known with CKD stage 2 - 3a
- •- Stable renal function during the 6 months preceding the study (eGFR 45-90
- •ml/min/1.73m2) with or without on stable therapy with RAAS inhibiting agents
- •- Albuminuria (> >200 mg/L in a morning urine sample / 500 - 3000mg/24 hrs)
排除标准
- •- An office blood pressure >140/90 mmHg;
- •- A body mass index >30 kg/m2;
- •- Use of systemic corticosteroids;
- •- Use of NSAIDs > 2 times a week;
- •- A major illness in the past 3 months of any significant chronic medical
- •illness that the Investigator would deem unfavourable enrolment, including
- •chronic inflammatory diseases, excluding the diseases of interest (DM2 and CKD)
- •- A history of any type of malignancy within the past 5 years with the
- •expectation of successfully treated basal cell cancer of the skin;
- •- A history of any auto-immune disease ;
- •- A history of cardiovascular disease (in the past 6 months) defined as
- •documented coronary artery disease including myocardial infarction, (un-)stable
- •angina pectoris or acute coronary syndrome, percutaneous transluminal coronary
- •angioplasty, coronary artery bypass grafting, cerebrovascular disease including
- •ischemic and haemorrhagic stroke or a subarachnodial bleeding, or peripheral
- •artery disease including aortic aneurysmata;
- •- A history of eye surgery, glaucoma of retinal disorder;
- •- A history, within 3 years, of drug abuse (including benzodiazepines, opioids,
- •amphetamine, cocaine, THC, methamphetamine);
- •- A history of alcoholism and/or drinking more than 3 units of alcohol per day.
- •Alcoholism is defined as an average weekly intake of >21 units for males. One
- •unit is equivalent to 9 g of alcohol: a half-pint (~ 240mL) of beer, 1 glass
- •(125 mL) of wine or 1 (25ml) measure of spirits;
- •- Smoking or use of tobacco products less than 30 days ago;
- •- Any other issue that in opinion of the Investigator could be harmful to the
- •subject or compromise interpretation of the data.
研究者
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