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临床试验/NL-OMON20689
NL-OMON20689招募中不适用

The role of glycosaminoglycans and macrophages in salt-sensitivity of blood pressure

Amsterdam UMC, location AMC0 个研究点目标入组 75 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
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

入选标准

  • All subjects:
  • -Age between 18 and 40 years;
  • -Office BP = 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;
  • -With microalbuminuria defined as: Either albuminuria 20-200 mg/L in a morning urine sample; or albuminuria 30-300 mg/24 hrs collected in a 24-hours urine collection; or albumin-to-creatinin ratio 2.5-25 mg/mmol in a morning urine sample
  • -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% (86 mmol/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;
  • -With albuminuria defined as: Either albuminuria >200 mg/L in a morning urine sample; or albuminuria 500 – 3000 mg/24 hrs collected in a 24-hours urine collection; or albumin-to-creatinin ratio >25 mg/mmol in a morning urine sample
  • Healthy volunteers:
  • -Healthy, as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination (PE) and laboratory tests carried out in the screening visit.

排除标准

  • -An office BP >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 and >14 units for women. One unit is equivalent to 9 g of alcohol: a half-pint (~ 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 ml) 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

发起方
Amsterdam UMC, location AMC

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