Cardiometabolic Disease Clinical Trial
Official title:
Metagenomics and Integrative Systems Medicine of Cardiometabolic Diseases
Supported by state-of-the-art systems medicine competences including integrative computational and functional genomics, the overarching goal of the trial is to investigate the impact of qualitative and quantitative changes in the gut microbiota on the pathogenesis of cardiometabolic diseases (CMDs) and their associated co-morbidities. A major objective will be to translate the clinical and fundamental based discoveries into new diagnosis and preventive actions paving the way to novel modes of treatment in the successive stages of CMD progression.
Cardiovascular diseases represent a huge medico-economic issue that is supported by public
health policy. It is linked not only to the high prevalence of these diseases but also the
associated cost they encounter for. Therefore, it seems rather urgent to create and validate
tools to predict evolution of this group of disease in order to better take care of patients
before they enter the more chronic stages which induce increased costs and socioeconomic and
medical burdens.
It is now well acknowledged that gut microbiota is modified in some metabolic disease such
as type-2 diabetes but also in inflammatory diseases. However, gut microbiota is still
insufficiently explored in cardiovascular disease, although it could represent a useful,
non-invasive and practical tool in the daily care of patients.
Investigators aim to deepen the knowledge and characterization of gut microbiota in patients
going from metabolic diseases such as metabolic syndrome, obesity and type 2 diabetes (which
are risks factors for cardiovascular diseases) to overt coronary artery diseases (from the
first event to end stage heart failure). Investigators will use a system medicine approach
whose aim is to integrate numerous data coming from different technologies (including
environment, transcriptomics, metabolomics, metagenomics, lipidomics and bioinformatics).
These integrated approaches are needed to translate basic science findings into clinical
practice for the benefit of the patients.
Investigators aim to uncover new microbial signatures that could help diagnose and/or
predict both the natural evolution of cardiometabolic diseases and the response to
treatment. Investigators aim to go forward personalized medicine.
Patients will be approached for enrolment during their hospitalization in the 3 centers
during the 24-month enrolment phase (WP3). Once the informed consent completed, each patient
will be assessed for CMD phenotypes including clinical examination, environmental and food
habit evaluation, blood urine and feces samples. In each group of patients, a sub-sample of
30 to 50 subjects will be included in one or more advanced phenotyping items. This will
include whole body composition by absorptiometry (DXA), abdominal visceral fat by
tomodensitometry, Oral Glucose Tolerance Test (OGTT) (glucose, insulin, incretins),
subcutaneous fat biopsy, cardiac echocardiography, intima media thickness, pulse wave
velocity. For the obese patients undergoing bariatric surgery: liver and subcutaneous and
omental adipose tissue biopsies will be obtained during surgery.
This group of patient will be followed at 3, 6 and 12 months after their surgery and will
have the same examination as mentioned above.
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
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