NCT04194372

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
43mo left

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Dec 2019Jan 2030

First Submitted

Initial submission to the registry

December 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2019

Completed
9 days until next milestone

Study Start

First participant enrolled

December 20, 2019

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

10 years

First QC Date

December 9, 2019

Last Update Submit

May 20, 2026

Conditions

Metabolic Disease

Keywords

DiabeticCardioVascular Diseasemorbi-mortalityHospital Cohort

Outcome Measures

Primary Outcomes (1)

  • number of death

    The number of patients dead according to national database

    at 10 years

Secondary Outcomes (5)

  • Occurrence of macrovascular complications (composite criteria)

    at 10 years

  • hospitalization for heart failure

    at 10 years

  • Occurence of renal microvasculare complications (composite criteria)

    at 10 years

  • Occurrence of liver complications(composite endpoint)

    at 10 years

  • Occurrence of hemorrhages measured by BARC >3 bleeding

    at 10 years

Study Arms (1)

Metabolic Patient

Patients with a metabolic desease, defined as 1. Metabolic Syndrom 2. Diabetic 3. Obese

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with pathologies associated with metabolic disease

You may qualify if:

  • 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
  • +13 more criteria

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ch Boulogne-Sur-Mer

Boulogne-sur-Mer, 59037, France

RECRUITING

Hop Cardiologique Chr Lille

Lille, 59037, France

RECRUITING

Hop Claude Huriez Chr Lille

Lille, 59037, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood, plasma, serum,nail appendage, hair

MeSH Terms

Conditions

Metabolic DiseasesCardiovascular Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

  • François Pattou, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

François Pattou, MD,PhD

CONTACT

03 20 44 42 73francois.pattou@chru-lille.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2019

First Posted

December 11, 2019

Study Start

December 20, 2019

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

May 22, 2026

Record last verified: 2026-05

Locations

FR(3)