Individual Factors Related to Chronic Low-grade Inflammation and Cardiometabolic Disease Risk

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorIntegrative Phenomics

About this trial

The goal of this observational study is to learn about low-grade inflammation in healthy individuals and individuals with overweight or obesity.

The main questions it aims to answer are:

* Whether it is possible to predict low-grade inflammation * What are the medical, biological, and lifestyle variables related to low-grade inflammation?

Participants will be asked to:

1. Attend a general medical visit to collect vital signs, anthropometric measurements, and collect blood samples. 2. Complete questionnaires and collect a stool sample at home.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male or female between the ages of 18 and 70 included,

Clinically at-risk group Body Mass Index between 25 (included) and up to 35 kg/m2 (excluded)

Non-clinically at-risk group Body Mass Index between 18.5 (included) and up to 25 kg/m2 (excluded) and absence of metabolic syndrome criteria

Subject covered by social security or a similar system.

Disqualifiers

Rheumatoid arthritis, reactive or psoriatic arthritis (non-osteoarthritis)

Inflammatory bowel disease (IBD) (Crohn's disease or ulcerative colitis) or irritable bowel syndrome

Systemic lupus erythematosus

Uncontrolled psoriasis

Trial population

Existing or new patients with overweight or obesity from primary care at La Pitié-Salpetriere Hospital in Paris, Marseille Public Hospital, Colmar Civil Hospital, Bordeaux University Hospital. Healthy volunteers throughout France.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

3,000 Participants
are grouped into 2 trial groups
Group A: Not clinically at-risk
Group B: Clinically at-risk

Trial outcomes

Primary outcomes

1

Low-grade inflammation

Assessed as a z-score composed of six markers (C reactive protein (CRP), interleukin (IL)-6, serum amyloid-A (SAA), soluble intracellular adhesion molecule (sICAM), tumor necrosis factor alpha (TNF)-alpha) and categorized into 3 tertiles: Low/ Moderate/High

Time frame
Baseline

Secondary outcomes

1

Gut microbiome metabolites

Consumption and production in mmol/day assessed through in silico metabolic modeling

Time frame
Baseline
2

Fasting glucose

Serum glucose in mg/dl

Time frame
Baseline
3

Stool microbiome composition

Relative abundance of microbiome taxonomies (Phyla, Order, Class, Family, Genus, Species), metagenomic species (MGS), and co-abundance genes (CAGs) in stool samples assessed through shot-gun sequencing

Time frame
Baseline
4

Stool microbiome functional pathways

Relative abundances of microbiome functional pathways assessed through metagenomics and in silico metabolic modeling

Time frame
Baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Integrative Phenomics

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Collaborator

Assistance Publique Hopitaux De Marseille

Collaborator

University Hospital, Bordeaux

Collaborator

Centre Hospitalier Universitaire Dijon

Collaborator

Institut Pasteur de Lille

Collaborator

Hopitaux Civils de Colmar

Collaborator

This trial is not recruiting at the moment. You can still explore other options: