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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Lille

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Unscheduled hospitalization less than 3 months old

Cytotoxic chemotherapy

Radiotherapy

HIV and / or HCV and / or active HBV infection

Trial population

patients with pathologies associated with metabolic disease

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

10,000 Participants
are grouped into 1 trial group
Group A: Metabolic Patient

Trial outcomes

Primary outcomes

1

number of death

The number of patients dead according to national database

Time frame
at 10 years

Secondary outcomes

1

Occurrence of macrovascular complications (composite criteria)

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

Time frame
at 10 years
2

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

Time frame
at 10 years
3

Occurence of renal microvasculare complications (composite criteria)

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

Time frame
at 10 years
4

Occurrence of liver complications(composite endpoint)

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

Time frame
at 10 years

Other outcomes

Sponsors and contacts

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