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

The role of glycosaminoglycans and macrophages in salt-sensitivity of blood pressure - SALT-3

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON55197
Enrollment
90
Registered
2020-02-13
Start date
2020-07-01
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fysiologie van natrium- en volumebalans Blood pressure salt-sensitivity

Interventions

High salt diet (>200 mmol Na+ daily) for 1 week and low salt diet (

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: All subjects: - Men and women Between 18 and 75 years of age - Office blood pressure >200 mg/L in a morning urine sample / 500 - 3000mg/24 hrs)

Exclusion criteria

Exclusion criteria: - 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.

Design outcomes

Primary

MeasureTime frame
The primary objective of this study is to explore in DKK and CKD patients the effects of dietary sodium on body fluid volume, as measured by BP, weight and bio-impedance measurements.

Secondary

MeasureTime frame
Secundary study parameters are expressed as the effect of salt intake on: - Skin sodium concentration - Microcirculatory changes - Glycosaminoglycan metabolism - Macrophage activation and lymphangiogenesis - Microbiome content

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)