Identifying mortality risk in patients with metabolic diseases
Signature of the Risk Profile of Mortality in a Hospital Cohort of Patients With Metabolic Diseases
This study is trying to find out what factors can help predict the risk of death in people with metabolic diseases by looking at their health data and biological samples.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 3 sites (Boulogne-sur-Mer and 2 other locations) |
| Trial ID | NCT04194372 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish a mortality risk profile for patients with metabolic diseases by analyzing clinical and biological parameters. It focuses on a hospital cohort, utilizing high throughput screening of biological samples to assess metabolomics, genetics, transcriptomics, and epigenomics. The study will collect follow-up data from the National System of Health Data to track hospitalizations and medical consultations. By identifying clinico-biological determinants, the study seeks to improve prediction models for mortality and complications associated with metabolic disorders.
Who should consider this trial
Good fit: Ideal candidates include patients with diabetes, obesity, or metabolic syndrome who have a history of cardiovascular or neurological complications.
Not a fit: Patients without metabolic diseases or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized management strategies that improve patient outcomes and slow disease progression.
How similar studies have performed: While similar studies have explored mortality risk in metabolic diseases, this approach utilizing a comprehensive OMICs analysis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boulogne-sur-Mer and 2 other locations
- Ch Boulogne-Sur-Mer — Boulogne-sur-Mer, France (Recruiting)
- Hop Cardiologique Chr Lille — Lille, France (Recruiting)
- Hop Claude Huriez Chr Lille — Lille, France (Recruiting)
Study contacts
- Principal investigator: François Pattou, MD,PhD — University Hospital, Lille
- Study coordinator: François Pattou, MD,PhD
- Email: francois.pattou@chru-lille.fr
- Phone: 03 20 44 42 73
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.