The goal is to get a better understanding about the role of innate immune cells and the development of ASCVD in obese subjects. We will look at the innate immune cells in blood and at the progenitor cells derived from the bonemarrow.
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The most important question is whether there is trained immunity in the bone
marrow progenitor cells of the subjects with the metabolic syndrome compared to
subjects without metabolic syndrome.
Secondary outcome
The two other study parameters are 1) whether there are characteristics of
trained immunity in the circulating monocytes, and 2) whether there is
heterogeneity in the circulating monocytes with respect to the trained
phenotype.
Background summary
Obesity is a major risk factor for atherosclerotic cardiovascular disease
(ASCVD), and it accounts for more than 2.5 million cardiovascular deaths each
year. Some people with obesity develop metabolic complications, including the
metabolic syndrome, a clustering of abdominal obesity, dyslipidaemia, glucose
intolerance and hypertension; whereas other obese individuals remain
metabolically healthy. The metabolic syndrome is an important risk factor for
the development of ASCVD.
Previous research has shown that innate immune cells play an important role in
ASCVD. With this study we want to investigate the role of progenitors of these
innate immune cells in the bonemarrow in subjects mentioned below. We hope this
will provide a better understanding in the development of ASCVD and possible
novel therapeutics targets in the future.
Study objective
The goal is to get a better understanding about the role of innate immune cells
and the development of ASCVD in obese subjects. We will look at the innate
immune cells in blood and at the progenitor cells derived from the bonemarrow.
Study design
Observational single center study
Study burden and risks
There is no direct benefit to the study participants. The risks for
participants are overall negligible, except for possible discomfort related to
the venepuncture and one time bone marrow aspiration which will be performed by
experienced personnel. After signing for informed consent, 10 ml blood will be
drawn for the confirmation of difference in cytokine production capacity.
Subsequently 50ml of blood will be drawn and 30ml of bone marrow aspirate.
These procedures don*t impose a risk for the participants, other than a
possible hematoma at the puncture site.
Geert Grooteplein Zuid 8
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 8
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
-Participant in 300OB cohort, so all have a BMI> 27 and age >18 years
-Males
-Written informed consent
-4 weeks prior to inclusion stop cholesterol lowering drugs such as: statins
Exclusion criteria
-Inability to personally provide written informed consent (e.g. for linguistic
or mental reasons)
-Documented bleeding diathesis or thrombocytopenia <50 *10e9/L
-History of haematological malignant disease
-Current treatment for maligancy
-Acute or chronic infections at the time of participation
-Medical history of any disease associated with immune deficiency (either
congenital or acquired, including chemotherapy, chronic steroid use, organ
transplant)
-Clinically significant infections within 1 months prior to study entry
(defined as fever >38.5)
-Previous vaccination within 1 months prior to study entry
-Chronic use of anti-inflammatory drugs such as NSAIDs (acetylsalicylic acid
<100 mg/day excluded)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL72484.091.20 |