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NCT Number: NCT04194372

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ch Boulogne-Sur-Mer, Boulogne-sur-Mer, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. number of death

    Time frame: at 10 years

    The number of patients dead according to national database

Secondary outcomes

  1. Occurrence of macrovascular complications (composite criteria)

    Time frame: at 10 years

    composite criteria: cardiovascular death, myocardial infarction, stroke, coronary revascularization, peripheral revascularization, amputation)

  2. hospitalization for heart failure

    Time frame: at 10 years

    The number of patients that has been hospitalized for heart failure since the end of the study according to national database

  3. Occurence of renal microvasculare complications (composite criteria)

    Time frame: at 10 years

    composite criteria: renal transplantation, dialysis, GFR >60, Albuminuria

  4. Occurrence of liver complications(composite endpoint)

    Time frame: at 10 years

    composite endpoint: hepatic fibrosis, cirrhosis, HCC, death from liver

  5. Occurrence of hemorrhages measured by BARC >3 bleeding

    Time frame: at 10 years

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

François Pattou, MD,PhD

CONTACT

[email protected]

03 20 44 42 73 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: INTEGRA

Important dates

Study start
2019
Primary completion
2030
Study completion
2030
First posted
Dec 11, 2019
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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