Targeting Glutamine Metabolism to Prevent Diabetic Cardiovascular Complications
France995 participantsStarted 2020-11-16
Plain-language summary
Experimental data suggest that glutamine catabolism in involved in the activation of macrophages by generating TCA(Tricarboxylic acid) intermediates that promote the pro-inflammatory polarization of macrophages. The project investigates the possible link between glutaminolysis, monocytes polarization and diabetes related cardiovascular complications in humans
Who can participate
Age range
18 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 General inclusion criteria applying to the five populations are the following:
* Age above 18 years
* BMI between 25 and 40 kg/m²
Inclusion criteria according to study group are listed below.
Group 1: Patients with uncomplicated diabetes and low cardiovascular risk, additional inclusion criteria are:
* 5 or more years of diabetes
* 6% \< HbA1c \< 10%
* no history of cardiovascular event, diabetic microvascular complications (kidney function normal and albuminuria/creatininuria \< 30 mg/g)
* Coronary artery calcium score \< 100 (assessment \< 12 months)
Group 2: Patients with uncomplicated diabetes and high cardiovascular risk, additional inclusion criteria are:
* 5 or more years of diabetes
* 6% \< HbA1c \< 10%
* no history of cardiovascular eventand diabetic nephropathy no more than stage 2 (i.e. GFR ≥ 60 ml/min by MDRD or CKD-EPI formula and albuminuria/creatininuria ≤ 30 mg/g)
* Coronary artery calcium score \> 400 (assessment \< 12 months)
Group 3: Patients with complicated diabetes, additional inclusion criteria are:
* 5 or more years of diabetes
* 6% \< HbA1c \< 10%
* A history of cardiovascular event (myocardial infarction, stroke, peripheral vascular disease, or angioplasty) at least 3 months ago
Exclusion Criteria:
* Solid organ or bone marrow transplant patient
* Pregnant or breastfeeding woman
* Absence of free and informed consent
* Non-affiliation to a social security regimen or CMU (universal health coverage)
* Subject deprived of fr…
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.
What they're measuring
1
Compare the plasma concentrations of glutamine in patients with various levels of cardiovascular (CV) risk.