Signature of the Risk Profile of Mortality in a Hospital Cohort of Patients With Metabolic Diseases

Metabolic Disease Clinical Trial

— INTEGRA  

Official title:

Signature of the Risk Profile of Mortality in a Hospital Cohort of Patients With Metabolic Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04194372
• Other study ID #: 2018_08
• Secondary ID: 2019-A01727-50
• Status: Recruiting
• Start date: December 20, 2019
• Est. completion date: January 2030

Study information

• Verified date: April 2022
• Source: University Hospital, Lille
• Contact: François Pattou, MD,PhD
• Phone: 03 20 44 42 73
• Email: francois.pattou[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: January 2030
• Est. primary completion date: January 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Disease
• Metabolic Diseases

Locations

Country	Name	City	State
France	Ch Boulogne-Sur-Mer	Boulogne-sur-Mer
France	Hop Cardiologique Chr Lille	Lille
France	Hop Claude Huriez Chr Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of death	The number of patients dead according to national database	at 10 years
Secondary	Occurrence of macrovascular complications (composite criteria)	composite criteria: cardiovascular death, myocardial infarction, stroke, coronary revascularization, peripheral revascularization, amputation)	at 10 years
Secondary	hospitalization for heart failure	The number of patients that has been hospitalized for heart failure since the end of the study according to national database	at 10 years
Secondary	Occurence of renal microvasculare complications (composite criteria)	composite criteria: renal transplantation, dialysis, GFR >60, Albuminuria	at 10 years
Secondary	Occurrence of liver complications(composite endpoint)	composite endpoint: hepatic fibrosis, cirrhosis, HCC, death from liver	at 10 years
Secondary	Occurrence of hemorrhages measured by BARC >3 bleeding	composite endpoint : CABG-related bleeding (Perioperative intracranial bleeding within 48 h / Reoperation after closure of sternotomy for the purpose of controlling bleeding / Transfusion of<5 U whole blood or packed red blood cells within a 48-hperiod / Chest tube output>=2L within a 24-h period); or Fatal Bleeding (Probable fatal bleeding; no autopsy or imaging confirmation butclinically suspicious / Definite fatal bleeding; overt bleeding or autopsy or imagingconfirmation)	at 10 years