NL-OMON46844已完成不适用
Role of endothelial surface layer in regulating the sodium balance and extracellular fluid volume - SALT-2 study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
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
- •1. Diabetic patients (n<=12)
- •- Male between 18 and 40 years old
- •- Known with Diabetes Mellitus - type 1
- •- With or without microalbuminuria defined as:
- •o either albuminuria 20-200 mg/L in a morning urine sample
- •o or albuminuria 30-300 mg/24 hrs collected in a 24-hours urine collection
- •o or albumin-to-creatinin ratio 2,5-25 mg/mmol in a morning urine sample.
- •- Stable renal function (creatine clearance > 60 ml/min and < 6 ml/min per year decline) with or without stable therapy with RAAS inhibiting agents
- •- HbA1c levels between 6.0 and 10.0% (42-86 mmol/mol) during the 6 months preceding the study
- •- Multiple injections of insulin a day
- •- Able to provide written informed consent and to comply with the requirements and restrictions listed in the informed consent form;2. HME patients (n<=12)
- •- Male between 18 and 40 years old
- •- Documented Hereditary Multiple Exostoses
- •- Stable renal function (creatinin clearance > 60 ml/min and < 6 ml/min per year decline, no proteinuria)
- •- Able to provide written informed consent and to comply with the requirements and restrictions listed in the informed consent form
排除标准
- •- An office blood pressure >140/90 mmHg
- •- A body mass index > 30 kg/m2
- •- A major illness in the past 3 months or any significant chronic medical illness that the Investigator would deem unfavourable for enrolment, including chronic inflammatory diseases
- •- A history of any type of malignancy within the past 5 years with the exception of successfully treated basal cell cancer of the skin
- •- A history of any renal 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, precutenaous transluminal coronary angioplasty, coronary artery bypass grafting, cerebrovascular disease including ischemic and hemorrhagic stroke or a subarachnodial bleeding, or peripheral artery disease including aortic aneurysmata
- •- A history of coagulation disorders
- •- A history of primary hyperlipoproteinemias
- •- A history of hypersensitivity or allergy to iodium or to shell fish
- •- A history, within 3 years, of drug abuse (including benzodiazepines, opioids, amphetamine, cocaine, THC, methamphetamine)
- •- A history of alcoholism and/or is 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 8 g of alcohol: a half-pint (~240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits
- •- Difficulty in donating blood or limited accessibility of a vein in left and right arm
- •- Subject has donated blood in last 3 months
- •- Use of tobacco products
- •- Any other issue that, in the opinion of the Investigator, could be harmful to the subject or compromise interpretation of the data
- •- Any clinically relevant abnormality noted on the 12-lead ECG as judged by the Investigator or an average QTcB or QTcF > 450 millisec
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