Clinical trial NCT04194372: Signature of the Risk Profile of Mortality in a Hospital Cohort of Patients With Metabolic Diseases
Official title: Signature of the Risk Profile of Mortality in a Hospital Cohort of Patients With Metabolic Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metabolic Disease
Keywords: Diabetic
CardioVascular Disease
morbi-mortality
Hospital Cohort
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with pathologies associated with metabolic disease

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.

Detailed description: The prediction of the onset of diabetes and metabolic complications, especially cardiovascular, renal, or hepatic, is a major challenge to optimize the management of this disease.

Teams from the University Hospital of Lille have developed the Integra cohort study to identify the clinical and biological determinants of the occurrence of these complications and the mortality of patients with metabolic disorders.

The aim of the study is to identify clinico-biological determinants that are able to predict the occurence of death, cardiovascular events as well as hepatic or nephrotic one.

Follow-up data will be collected from National System of Health Data (SNDS) where data concerning hospitalisations, medical consultations and treatments are registered.

Biological samples are collected at baseline for a large OMICs analysis (metabolomics, genetics, transcriptomics and epigenomics) that would feed our predictive scoring system.

This project will allow us to describe new models of prediction of metabolic diseases and its complications, and to offer adapted and personalised methods of management, which can slow the progression of the disease and improve its prognosis.

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

Primary outcomes:
measure: number of death
timeFrame: at 10 years
Secondary outcomes:
measure: Occurrence of macrovascular complications (composite criteria)
timeFrame: at 10 years
measure: hospitalization for heart failure
timeFrame: at 10 years
measure: Occurence of renal microvasculare complications (composite criteria)
timeFrame: at 10 years
measure: Occurrence of liver complications(composite endpoint)
timeFrame: at 10 years
measure: Occurrence of hemorrhages measured by BARC >3 bleeding
timeFrame: at 10 years
Other outcomes:
Locations:
city: Boulogne-sur-Mer
country: France
facility: Ch Boulogne-Sur-Mer
city: Lille
country: France
facility: Hop Cardiologique Chr Lille
city: Lille
country: France
facility: Hop Claude Huriez Chr Lille
Study officials:
affiliation: University Hospital, Lille
name: François Pattou, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: