high blood pressure hypertension
Conditions
Interventions
dietary intervention: low sodium diet (200 mmol Na+/d)
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: All patients - Male between 18 and 40 years of age - Non-treated 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, DM1 patients - 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 60 ml/min and 60 ml/min and
Exclusion criteria
Exclusion criteria: Patients meeting any of the following exclusion criteria are not to be enrolled in the study: - 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 or any significant chronic medical illness that the Investigator would deem unfavourable for enrolment, including chronic inflammatory diseases, excluding the diseases of interest (DM1 and psoriatic arthritis) - 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 any auto-immune disease other than DM1 and psoriatic arthritis - 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 eye-surgery, glaucoma or retinal eye 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 8 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 then 30 days ago - Any other issue that in opinion of the Investigator could be harmful to the subject or compromise interpretation of data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be body weight and blood pressure, as represented by the mean arterial pressure. Several secondary endpoints are proposed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Concerning effects of sodium intake on microcirculation, the endpoint will be capillary density and perfusion as assessed by Sidestream Darkfield (SDF) imaging and retinal vascular imaging, in response to a high and a low sodium diet. We will investigate whether changes in these parameters correlate with changes in the macrocirculation. The influence of administration of nitroglycerin, an endothelial-independent vasodilator, on microcirculatory changes in the setting of either low or high salt intake will also be examined. Concerning the effects of sodium intake on the immune system, we will assess T-lymphocyte populations (i.e. IL-17, Th17), neutrophil subpopulations, and monocyte subpopulations, by flow cytometry in different sodium conditions. | — |
Countries
Netherlands
Outcome results
None listed