Metabolic DiseaseINTEGRANCT04194372
Signature of the Risk Profile of Mortality in a Hospital Cohort of Patients With Metabolic Diseases
An observational study of Metabolic Disease, run by University Hospital, Lille at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Disease
- How many people
- 10,000 participants
- Where
- 3 sitesFrance
- Study dates
- 20 Dec 2019to Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with pathologies associated with metabolic disease
Who may be able to join
- 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
Show all 28Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Ch Boulogne-Sur-Mer
Boulogne-sur-Mer, 59037
- Recruiting
Hop Cardiologique Chr Lille
Lille, 59037
0320445962
- Recruiting
Hop Claude Huriez Chr Lille
Lille, 59037
0320445962
About this study
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.
Read the 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.
- Conditions
- Metabolic Disease
- Keywords
- Diabetic, CardioVascular Disease, morbi-mortality, Hospital Cohort
- Medical subject headings
- Metabolic Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Metabolic Patient | Patients with a metabolic desease, defined as 1. Metabolic Syndrom 2. Diabetic 3. Obese |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of death
The number of patients dead according to national database
Measured: at 10 years
Secondary outcomes (5)
Occurrence of macrovascular complications (composite criteria)
composite criteria: cardiovascular death, myocardial infarction, stroke, coronary revascularization, peripheral revascularization, amputation)
Measured: at 10 years
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
Measured: at 10 years
Occurence of renal microvasculare complications (composite criteria)
composite criteria: renal transplantation, dialysis, GFR >60, Albuminuria
Measured: at 10 years
Occurrence of liver complications(composite endpoint)
composite endpoint: hepatic fibrosis, cirrhosis, HCC, death from liver
Measured: at 10 years
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)
Measured: at 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start20 Dec 2019
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Pattou, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194372
- Sponsor's protocol ID
- 2018_08
- Other IDs
- 2019-A01727-50
- Acronym
- INTEGRA
- Status last verified
- May 2026
- First submitted
- 9 Dec 2019
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Signature of the Risk Profile of Mortality in a Hospital Cohort of Patients With Metabolic Diseases
- ClinicalTrials.gov ID
- NCT04194372
- Acronym / sponsor ID
- INTEGRA / 2018_08
- Conditions
- Metabolic Disease
- Keywords
- Diabetic, CardioVascular Disease, morbi-mortality, Hospital Cohort
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metabolic Patient | – | –Patients with a metabolic desease, defined as 1. Metabolic Syndrom 2. Diabetic 3. Obese |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with pathologies associated with metabolic disease
Key inclusion criteria (28 listed)
- 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)
Key exclusion criteria (7 listed)
- Unscheduled hospitalization less than 3 months old
- Ongoing treatment :
- HIV and / or HCV and / or active HBV infection
- OMS score> = 2
- Pregnant woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of death
Time frame: at 10 years
The number of patients dead according to national database
5 secondary outcomes
Occurrence of macrovascular complications (composite criteria)
Time frame: at 10 years
hospitalization for heart failure
Time frame: at 10 years
Occurence of renal microvasculare complications (composite criteria)
Time frame: at 10 years
Occurrence of liver complications(composite endpoint)
Time frame: at 10 years
Occurrence of hemorrhages measured by BARC >3 bleeding
Time frame: at 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
François Pattou, MD,PhD principal investigator
University Hospital, Lille
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Disease, run by University Hospital, Lille at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact François Pattou, MD,PhD (03 20 44 42 73 ext. +33, francois.pattou@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of death (time frame: at 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.