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ID
Source
Brief title
Health condition
(risk for) Cardiovascular disease
Sponsors and support
Intervention
Outcome measures
Primary outcome
Define the environmental and biological factors that drive skin sodium accumulation according to the novel 3-compartment concept in the skin of children, and to investigate whether these factors are associated with risk factors for future cardiovascular disease.
Secondary outcome
The association between skin sodium accumulation and alterations in GAG metabolism and local immune cell infiltration.
Background summary
The role of high sodium intake in blood pressure (BP) and worse cardiovascular health has been extensively investigated, but is to date still incompletely understood. For a long time, it was thought that sodium homeostasis in the body was based on a two-compartment model. This theory assumed that an increase in dietary salt intake leads to a water shift from the intracellular to the extracellular compartment, thirst and increased renal water reabsorption. These effects, to maintain plasma osmolality, increase the extracellular volume which was considered to be mainly responsible for BP increases. However, consecutive long-term sodium balance studies have shown no weight gain or increase in total body water during a high sodium intake. It was found that sodium can accumulate without concurrent water retention in the tissue interstitium and the endothelial surface layer (ESL), thus forming a third sodium compartment in the body. Highly sulfated glycosaminolgycans (GAGs) are thought to facilitate tissue sodium accumulation. Many studies are investigating how this sodium accumulating compartment is affecting BP regulation, by studying the activation of macrophages and microcirculation. Large variations in skin sodium accumulation capacity have been found in various pathological conditions associated with worse cardiovascular health, including BP. Whether this third compartment is relevant in early life and whether alterations of tissue sodium accumulation at young age may translate in BP alterations and worse cardiovascular (CV) outcome later in life is unknown.
Study objective
1. Young children with ≥1 risk factors (environmental and genetic) for worse cardiovascular health later in life have already increased non-osmotic sodium buffering in the skin.
2. Sodium buffering in the skin of young children is associated with sulfatation of skin glycosaminoglycans, skin lymph vessel density and the influx of activated macrophages, resulting in an increased inflammatory state in these children.
3. Since in adults the association between sodium accumulation and BP is present, we expect that children above 5 years of age with increased sodium content in the skin will have higher BP.
Study design
Skin collection during circumcision - one appointment for measuring blood pressure (age>5 years)
Intervention
N/A
Inclusion criteria
- Healthy, male children under 12 years of age undergoing a circumcision
- Parents / caregivers capable of giving written informed consent and able to comply with the requirements listed in the informed consent form.
Exclusion criteria
- Childeren above 12 years of age
- Unwillingness from the parents to let their child participate in the study
- One or both parents who are not capable of reading and understanding the Dutch patient information letter
- Parents who are not capable of giving written informed consent and able to comply with the requirements listed in the informed consent form
- Contraindication for circumcision
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL9126 |
| Other | METC AMC : METC 2020_111 |