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

Recruiting

• Conditions: Fysiologie van natrium- en volumebalans; Blood pressure; salt-sensitivity

• Registration Number: NL-OMON55197
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 75

Inclusion Criteria

All subjects:
- Men and women Between 18 and 75 years of age
- 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

Microalbuminuric type 2 diabetes patients:
- Known with Diabetes Mellitus type 2
- Either albuminuria (20-200 mg/L in a morning urine sample / 30-300 mg/24 hrs)
- 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% (86mmol/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
- Albuminuria (> >200 mg/L in a morning urine sample / 500 - 3000mg/24 hrs)

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this study is to explore in DKK and CKD patients the<br /><br>effects of dietary sodium on body fluid volume, as measured by BP, weight and<br /><br>bio-impedance measurements. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary study parameters are expressed as the effect of salt intake on:<br />- Skin sodium concentration<br />- Microcirculatory changes<br />- Glycosaminoglycan metabolism<br />- Macrophage activation and lymphangiogenesis</p>