Individual Factors Related to Chronic Low-grade Inflammation and Cardiometabolic Disease Risk (NCT06355544) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Individual Factors Related to Chronic Low-grade Inflammation and Cardiometabolic Disease Risk
3,000 participantsStarted 2024-04
Plain-language summary
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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female between the ages of 18 and 70 included,
* One of the following two criteria:
* 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.
* Ability to use a mobile phone application on a daily basis (food intake).
* Subject, after being informed of the contents of this study, fully understanding and accepting its purpose; and able to personally sign a written informed consent
Exclusion Criteria:
* Subject with diagnosed inflammatory disease or infection-related inflammation (viral or bacterial) or medical history (viral) within the last 2 months:
* 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
* Viral hepatitis or ongoing viral infection
* Seasonal virus (influenza-like illness)
* Subjects who have taken antibiotics in the last 2 months
* Subject under treatment within the last 2 months of an:
* Antiviral (for HIV, hepatitis, influenza, chickenpox/shingles)
* Oral, topical, or injectable treatment of a drug that modulates the inflammatory response (e.g. Corticosteroid, non-steroidal anti-inflammatory drugs (e.g. ibu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.