NCT04194372 Signature of the Risk Profile of Mortality in a Hospital Cohort of Patients With Metabolic Diseases
| NCT ID | NCT04194372 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Lille |
| Condition | Metabolic Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2019-12-20 |
| Primary Completion | 2030-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2019-12-20 with a primary completion date of 2030-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Epidemiological studies are usually conducted in the general population in adults without complications or pathology at baseline. The results obtained are therefore often better designed for primary prevention use. The prediction of mortality risk in patients with complications and requiring hospital follow-up is less well known. The study purpose is to determine a mortality risk profile in a hospital cohort of patients with pathologies associated with metabolic diseases. Today the "multimaker" scores based on a panel of biomarkers - have significantly improved the discriminating power of prediction models existing in many pathologies. It is no longer a single biomarker that can improve risk prediction but a complete and cross-sectional profile that is sought after. We aim to establish a personalised mortality risk profile by combining clinical and biological parameters including metabolomics, genetics, transcriptomics and epigenomics by high throughput screening of biological samples.
Eligibility Criteria
Inclusion Criteria: * Diabetic: antecedent - treatment - or glycemia\> = 1.26 g / dl - or HbA1C\> = 6.5% and or * Obese: BMI\> = 30 and or * Metabolic syndrome defined AND * Patient having given written consent to participate in the study or collection of the consent of the witness * Social insured patient (excluding AME) * Patient willing to comply with all procedures of the study and its duration AND Patient also presenting a pathology among: * Cardiology: * Coronary patient(history of myocardial infarction, coronary bypass, or coronary angioplasty or stenosis greater than 50% on an epicardial vessel documented on coronary angiography) * Patient with systolic or diastolic heart failure * Patient with atrial fibrillation * Patient with aortic stenosis (Vmax\> 2.5 m / s) * Patient with high blood pressure * neurology: * ischemic stroke * intracerebral hemorrhage * transient ischemic attack * diabetology: * Obesity without diabetes * Diabetes T2 * T1 diabetes * Monogenic Diabetes / MODY * African Diabetes * Diabetes secondary to pancreatopathy / liver cirrhosis * Diabetes post transplantation / post immunotherapy * Diabetes associated with Steinert's disease * hepatology: hepatological pathology * nephrology: nephrology Exclusion Criteria: * Unscheduled hospitalization less than 3 months old * Ongoing treatment : * Cytotoxic chemotherapy * Radiotherapy * HIV and / or HCV and / or active HBV infection * OMS score\> = 2 * Pregnant woman
Contact & Investigator
François Pattou, MD,PhD
PRINCIPAL INVESTIGATOR
University Hospital, Lille
Frequently Asked Questions
Who can join the NCT04194372 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metabolic Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04194372 currently recruiting?
Yes, NCT04194372 is actively recruiting participants. Contact the research team at francois.pattou@chru-lille.fr for enrollment information.
Where is the NCT04194372 trial being conducted?
This trial is being conducted at Boulogne-sur-Mer, France, Lille, France, Lille, France.
Who is sponsoring the NCT04194372 clinical trial?
NCT04194372 is sponsored by University Hospital, Lille. The principal investigator is François Pattou, MD,PhD at University Hospital, Lille. The trial plans to enroll 10,000 participants.