Influence of saltintake on Microcirculation and immune System

Withdrawn

• Conditions: 10057166; hypertension; 10027665; high blood pressure

• Registration Number: NL-OMON50531
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 54

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 < 6 ml/min
per year decline)
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
- Multiple injections of insulin a day, Psoriatic arthritis patients
without IL-17 inhibitors
- Known with psoriatic arthritis, stable disease activity (mild or in
remission) as clinically
assessed by the treating rheumatologist
- Stable renal function (creatinin clearance > 60 ml/min and < 6 ml/min per
year decline, no
overt proteinuria)
- Without use of IL-17 inhibitors, IL-10 inhibitors, IL-23 inhibitors, and
leflunomide, Psoriatic arthritis patients with IL-17 inhibitors
- Known with psoriatic arthritis, stable disease activity (mild or in
remission) as clinically
assessed by the treating rheumatologist
- Stable renal function (creatinin clearance > 60 ml/min and < 6 ml/min per
year decline, no
overt proteinuria)
- Use of IL-17 inhibitors at least 3 months before screening

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint will be body weight and blood pressure, as represented by<br /><br>the mean arterial pressure. Several secondary endpoints are proposed. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Concerning effects of sodium intake on microcirculation, the endpoint will be<br /><br>capillary density and perfusion as assessed by Sidestream Darkfield (SDF)<br /><br>imaging and retinal vascular imaging, in response to a high and a low sodium<br /><br>diet. We will investigate whether changes in these parameters correlate with<br /><br>changes in the macrocirculation. The influence of administration of<br /><br>nitroglycerin, an endothelial-independent vasodilator, on microcirculatory<br /><br>changes in the setting of either low or high salt intake will also be examined.<br /><br>Concerning the effects of sodium intake on the immune system, we will assess<br /><br>T-lymphocyte populations (i.e. IL-17, Th17), neutrophil subpopulations, and<br /><br>monocyte subpopulations, by flow cytometry in different sodium conditions. </p><br>