The role of glycosaminoglycans and macrophages in salt-sensitivity of blood pressure
- Conditions
- Salt-sensitive hypertension - chronic kidney disease - diabetic kidney disease
- Registration Number
- NL-OMON20689
- Lead Sponsor
- Amsterdam UMC, location AMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 75
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.
-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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is to explore in DKD and CKD patients the effects of dietary sodium on body fluid volume, as measured by BP, weight and bio-impedance measurements.
- Secondary Outcome Measures
Name Time Method The evaluation of the attribution of new sodium handling mechanisms (skin sodium storage, glycosaminoglycan metabolism, microcirculatory changes, immune system activation) to the response of body fluid volume to different salt intakes. <br>