Metagenomics and Integrative Systems Medicine of Cardiometabolic Diseases
NCT ID: NCT02059538
Last Updated: 2014-08-29
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
2350 participants
Study Classification
INTERVENTIONAL
Study Start Date
2013-06-30
Study Completion Date
2016-06-30
Brief Summary
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Supported by state-of-the-art systems medicine competences including integrative computational and functional genomics, the overarching goal of the trial is to investigate the impact of qualitative and quantitative changes in the gut microbiota on the pathogenesis of cardiometabolic diseases (CMDs) and their associated co-morbidities. A major objective will be to translate the clinical and fundamental based discoveries into new diagnosis and preventive actions paving the way to novel modes of treatment in the successive stages of CMD progression.
Detailed Description
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Cardiovascular diseases represent a huge medico-economic issue that is supported by public health policy. It is linked not only to the high prevalence of these diseases but also the associated cost they encounter for. Therefore, it seems rather urgent to create and validate tools to predict evolution of this group of disease in order to better take care of patients before they enter the more chronic stages which induce increased costs and socioeconomic and medical burdens.
It is now well acknowledged that gut microbiota is modified in some metabolic disease such as type-2 diabetes but also in inflammatory diseases. However, gut microbiota is still insufficiently explored in cardiovascular disease, although it could represent a useful, non-invasive and practical tool in the daily care of patients.
Investigators aim to deepen the knowledge and characterization of gut microbiota in patients going from metabolic diseases such as metabolic syndrome, obesity and type 2 diabetes (which are risks factors for cardiovascular diseases) to overt coronary artery diseases (from the first event to end stage heart failure). Investigators will use a system medicine approach whose aim is to integrate numerous data coming from different technologies (including environment, transcriptomics, metabolomics, metagenomics, lipidomics and bioinformatics). These integrated approaches are needed to translate basic science findings into clinical practice for the benefit of the patients.
Investigators aim to uncover new microbial signatures that could help diagnose and/or predict both the natural evolution of cardiometabolic diseases and the response to treatment. Investigators aim to go forward personalized medicine.
Patients will be approached for enrolment during their hospitalization in the 3 centers during the 24-month enrolment phase (WP3). Once the informed consent completed, each patient will be assessed for CMD phenotypes including clinical examination, environmental and food habit evaluation, blood urine and feces samples. In each group of patients, a sub-sample of 30 to 50 subjects will be included in one or more advanced phenotyping items. This will include whole body composition by absorptiometry (DXA), abdominal visceral fat by tomodensitometry, Oral Glucose Tolerance Test (OGTT) (glucose, insulin, incretins), subcutaneous fat biopsy, cardiac echocardiography, intima media thickness, pulse wave velocity. For the obese patients undergoing bariatric surgery: liver and subcutaneous and omental adipose tissue biopsies will be obtained during surgery.
This group of patient will be followed at 3, 6 and 12 months after their surgery and will have the same examination as mentioned above.
It is now well acknowledged that gut microbiota is modified in some metabolic disease such as type-2 diabetes but also in inflammatory diseases. However, gut microbiota is still insufficiently explored in cardiovascular disease, although it could represent a useful, non-invasive and practical tool in the daily care of patients.
Investigators aim to deepen the knowledge and characterization of gut microbiota in patients going from metabolic diseases such as metabolic syndrome, obesity and type 2 diabetes (which are risks factors for cardiovascular diseases) to overt coronary artery diseases (from the first event to end stage heart failure). Investigators will use a system medicine approach whose aim is to integrate numerous data coming from different technologies (including environment, transcriptomics, metabolomics, metagenomics, lipidomics and bioinformatics). These integrated approaches are needed to translate basic science findings into clinical practice for the benefit of the patients.
Investigators aim to uncover new microbial signatures that could help diagnose and/or predict both the natural evolution of cardiometabolic diseases and the response to treatment. Investigators aim to go forward personalized medicine.
Patients will be approached for enrolment during their hospitalization in the 3 centers during the 24-month enrolment phase (WP3). Once the informed consent completed, each patient will be assessed for CMD phenotypes including clinical examination, environmental and food habit evaluation, blood urine and feces samples. In each group of patients, a sub-sample of 30 to 50 subjects will be included in one or more advanced phenotyping items. This will include whole body composition by absorptiometry (DXA), abdominal visceral fat by tomodensitometry, Oral Glucose Tolerance Test (OGTT) (glucose, insulin, incretins), subcutaneous fat biopsy, cardiac echocardiography, intima media thickness, pulse wave velocity. For the obese patients undergoing bariatric surgery: liver and subcutaneous and omental adipose tissue biopsies will be obtained during surgery.
This group of patient will be followed at 3, 6 and 12 months after their surgery and will have the same examination as mentioned above.
Conditions
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Cardiometabolic Disease
Keywords
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Obesity
Type 2 diabetes
Coronary artery diseases
Microbiota
Omics (ie transcriptomics, metabolomics, metagenomics, lipidomics)
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
SCREENING
Blinding Strategy
NONE
Study Groups
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Group 1
Metabolic syndrome
Group Type
OTHER
Adipose tissue biopsies (omental and subcutaneous) liver
Intervention Type
OTHER
CT-scan
Intervention Type
RADIATION
Stools sampling
Intervention Type
OTHER
DNA sampling
Intervention Type
OTHER
Blood sampling
Intervention Type
OTHER
Urine sampling
Intervention Type
OTHER
Dual energy X-ray absorptiometry-scan (DEXA-scan)
Intervention Type
RADIATION
Group 2
Severly obese patients
Group Type
OTHER
Adipose tissue biopsies (omental and subcutaneous) liver
Intervention Type
OTHER
CT-scan
Intervention Type
RADIATION
Stools sampling
Intervention Type
OTHER
DNA sampling
Intervention Type
OTHER
Blood sampling
Intervention Type
OTHER
Urine sampling
Intervention Type
OTHER
Dual energy X-ray absorptiometry-scan (DEXA-scan)
Intervention Type
RADIATION
Group 3
Type-2 diabetics patients
Group Type
OTHER
Adipose tissue biopsies (omental and subcutaneous) liver
Intervention Type
OTHER
CT-scan
Intervention Type
RADIATION
Stools sampling
Intervention Type
OTHER
DNA sampling
Intervention Type
OTHER
Blood sampling
Intervention Type
OTHER
Urine sampling
Intervention Type
OTHER
Dual energy X-ray absorptiometry-scan (DEXA-scan)
Intervention Type
RADIATION
Group 4
Patients with first recent (\< 2 weeks) acute coronary syndrome (ACS)
Group Type
OTHER
Adipose tissue biopsies (omental and subcutaneous) liver
Intervention Type
OTHER
CT-scan
Intervention Type
RADIATION
Stools sampling
Intervention Type
OTHER
DNA sampling
Intervention Type
OTHER
Blood sampling
Intervention Type
OTHER
Urine sampling
Intervention Type
OTHER
Dual energy X-ray absorptiometry-scan (DEXA-scan)
Intervention Type
RADIATION
Group 5
Patients with stable chronic coronary artery disease without heart failure
Group Type
OTHER
Adipose tissue biopsies (omental and subcutaneous) liver
Intervention Type
OTHER
CT-scan
Intervention Type
RADIATION
Stools sampling
Intervention Type
OTHER
DNA sampling
Intervention Type
OTHER
Blood sampling
Intervention Type
OTHER
Urine sampling
Intervention Type
OTHER
Dual energy X-ray absorptiometry-scan (DEXA-scan)
Intervention Type
RADIATION
Group 6
Patients with ischemic systolic heart failure (CHF)
Group Type
OTHER
Adipose tissue biopsies (omental and subcutaneous) liver
Intervention Type
OTHER
CT-scan
Intervention Type
RADIATION
Stools sampling
Intervention Type
OTHER
DNA sampling
Intervention Type
OTHER
Blood sampling
Intervention Type
OTHER
Urine sampling
Intervention Type
OTHER
Dual energy X-ray absorptiometry-scan (DEXA-scan)
Intervention Type
RADIATION
Group 7
Patients with non-ischemic chronic heart failure
Group Type
OTHER
Adipose tissue biopsies (omental and subcutaneous) liver
Intervention Type
OTHER
CT-scan
Intervention Type
RADIATION
Stools sampling
Intervention Type
OTHER
DNA sampling
Intervention Type
OTHER
Blood sampling
Intervention Type
OTHER
Urine sampling
Intervention Type
OTHER
Dual energy X-ray absorptiometry-scan (DEXA-scan)
Intervention Type
RADIATION
Group 8
Healthy volunteers
Group Type
OTHER
Stools sampling
Intervention Type
OTHER
DNA sampling
Intervention Type
OTHER
Blood sampling
Intervention Type
OTHER
Urine sampling
Intervention Type
OTHER
Dual energy X-ray absorptiometry-scan (DEXA-scan)
Intervention Type
RADIATION
Interventions
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Adipose tissue biopsies (omental and subcutaneous) liver
Intervention Type
OTHER
CT-scan
Intervention Type
RADIATION
Stools sampling
Intervention Type
OTHER
DNA sampling
Intervention Type
OTHER
Blood sampling
Intervention Type
OTHER
Urine sampling
Intervention Type
OTHER
Dual energy X-ray absorptiometry-scan (DEXA-scan)
Intervention Type
RADIATION
Eligibility Criteria
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Inclusion Criteria
Group 1 : metabolic syndrome As defined by the IDF
* Central obesity: defined as waist circumference \> 94 cm for European men and \> 80 cm for European women (with knowledge on ethnicity for other groups)
* plus 2 of the following criteria out of 4:
* Elevated blood pressure with systolic ≥ 130 mmHg and/or diastolic ≥85 mmHg (or patients receiving anti-hypertensive drug treatment)
* Triglycerides ≥1.50mg/dl (1.71mmol/l) (or patients receiving drug treatment for elevated triglycerides)
* HDL-c\<40mg/dl (1.03 mmol/l) in males or HDL-c\<50mg/dl (1.29mmol/l) in females (or patients receiving drug treatment that reduces HDL-c)
* Elevated fasting glucose: Glycemia ≥100mg/dl
* Aged 18 to 75 years old
To avoid overlapping with the other groups (in particular group III): only patients with normal glucose tolerance (NGT), impaired glucose tolerance (IGT) and/or impaired fasting glucose (IFG) and an HbA1c \< 6.5 % will be included in this group.
Group II: severely Obese patients
* Aged 18 to 75 years old
* BMI ≥35kg/m²
* Half of the effective will be standard obese patients (150 in Paris and 150 in Leipzig)
* Half of the effective will be patients candidate to a bariatric surgery either Sleeve gastrectomy or Roux-en-Y bypass (with the following clinical conditions: according to European and national guidelines for obesity surgery):
* BMI ≥40 kg/m² or
* BMI ≥35kg/m² with at least 1 obesity-related comorbidity (Hypertension, dyslipidemia, obstructive sleep apnea, joints disease and even type 2 diabetes).those can have past history of coronary diseases.
These patients will be followed during the first year after surgery. The clinical and research investigation time points will be 3, 6 and 12 months after the surgery.
Group 3: type 2 diabetes
Patients with known type 2 diabetes ie:
* Fasting plasma glucose (FPG) ≥7 mM (=1.26g/l) without treatment or Patients with HbA1c ≥ 6.5% (48 mmol/mol) without treatment or Patients treated with any anti diabetic agent whatever the HbA1c level at the day of the study \<10%
* BMI ≥ 25kg/m²
* No symptomatic CAD and previous CVD events
* with all stages of albuminuria
* Aged 18-75 years old
Group 4
\- Aged 18-75 years ACS without persistent ST elevation (ST-) Or ACS with persistent ST elevation (STEMI)
Group 5
* Aged 18-75 years
* Stable CAD is defined by
* CAD:ie (Previous documented ACS or previous coronary dilatation \>6 months or previous planned PCI showing a significant CAD (coronary stenosis \> 30 % in at least on major coronary artery) leading or not to a PCI / stent implantation) and Stable ie: (previous surgical coronary revascularization (CABG \> 6 month) or no symptoms or stable angina for 6 months and Without heart failure ie: (Left ventricular ejection fraction ≥ 45 %)
Group 6 Part of this group will be recruited during or immediately after a hospitalization for acute heart failure and Another part of the group will be at the stage in chronic heart failure with no recent acute event (no acute decompensation \< 3 month)
chronic Cardiac disease :ie Duration of chronic heart failure \> 6 months, or NYHA 2-4 or past history of clinical insufficiency decompensation or CHF due to LV systolic dysfunction (LV ejection fraction \< 45 %) and Past history of ACS and /or documented CAD ie (stenosis \> 30 % in \> 1 coronary artery or previous revascularization \>6months) and Aged 18 to 75 years old
Group 7 Half of this group will be recruited during or immediately after a hospitalization for acute heart failure (\< 1 month) and half in chronic stable heart failure (no acute decompensation \< 3 month) chronic cardiac disease non ischemic ie: (Documented coronary angiogram showing non-significant CAD) cardiac insufficiency ie: (LV ejection fraction \< 45 %, or NYHA 2-4 or past history of clinical insufficiency decompensation) and No valvular etiology and No symptoms and no angina and Aged 18 to 75 years old Group 8
* Age and sex matched to the patients cohorts
* Lean (19kg/m² \< BMI \<25 kg/m²)
* Aged 18 to 75 years old
* Central obesity: defined as waist circumference \> 94 cm for European men and \> 80 cm for European women (with knowledge on ethnicity for other groups)
* plus 2 of the following criteria out of 4:
* Elevated blood pressure with systolic ≥ 130 mmHg and/or diastolic ≥85 mmHg (or patients receiving anti-hypertensive drug treatment)
* Triglycerides ≥1.50mg/dl (1.71mmol/l) (or patients receiving drug treatment for elevated triglycerides)
* HDL-c\<40mg/dl (1.03 mmol/l) in males or HDL-c\<50mg/dl (1.29mmol/l) in females (or patients receiving drug treatment that reduces HDL-c)
* Elevated fasting glucose: Glycemia ≥100mg/dl
* Aged 18 to 75 years old
To avoid overlapping with the other groups (in particular group III): only patients with normal glucose tolerance (NGT), impaired glucose tolerance (IGT) and/or impaired fasting glucose (IFG) and an HbA1c \< 6.5 % will be included in this group.
Group II: severely Obese patients
* Aged 18 to 75 years old
* BMI ≥35kg/m²
* Half of the effective will be standard obese patients (150 in Paris and 150 in Leipzig)
* Half of the effective will be patients candidate to a bariatric surgery either Sleeve gastrectomy or Roux-en-Y bypass (with the following clinical conditions: according to European and national guidelines for obesity surgery):
* BMI ≥40 kg/m² or
* BMI ≥35kg/m² with at least 1 obesity-related comorbidity (Hypertension, dyslipidemia, obstructive sleep apnea, joints disease and even type 2 diabetes).those can have past history of coronary diseases.
These patients will be followed during the first year after surgery. The clinical and research investigation time points will be 3, 6 and 12 months after the surgery.
Group 3: type 2 diabetes
Patients with known type 2 diabetes ie:
* Fasting plasma glucose (FPG) ≥7 mM (=1.26g/l) without treatment or Patients with HbA1c ≥ 6.5% (48 mmol/mol) without treatment or Patients treated with any anti diabetic agent whatever the HbA1c level at the day of the study \<10%
* BMI ≥ 25kg/m²
* No symptomatic CAD and previous CVD events
* with all stages of albuminuria
* Aged 18-75 years old
Group 4
\- Aged 18-75 years ACS without persistent ST elevation (ST-) Or ACS with persistent ST elevation (STEMI)
Group 5
* Aged 18-75 years
* Stable CAD is defined by
* CAD:ie (Previous documented ACS or previous coronary dilatation \>6 months or previous planned PCI showing a significant CAD (coronary stenosis \> 30 % in at least on major coronary artery) leading or not to a PCI / stent implantation) and Stable ie: (previous surgical coronary revascularization (CABG \> 6 month) or no symptoms or stable angina for 6 months and Without heart failure ie: (Left ventricular ejection fraction ≥ 45 %)
Group 6 Part of this group will be recruited during or immediately after a hospitalization for acute heart failure and Another part of the group will be at the stage in chronic heart failure with no recent acute event (no acute decompensation \< 3 month)
chronic Cardiac disease :ie Duration of chronic heart failure \> 6 months, or NYHA 2-4 or past history of clinical insufficiency decompensation or CHF due to LV systolic dysfunction (LV ejection fraction \< 45 %) and Past history of ACS and /or documented CAD ie (stenosis \> 30 % in \> 1 coronary artery or previous revascularization \>6months) and Aged 18 to 75 years old
Group 7 Half of this group will be recruited during or immediately after a hospitalization for acute heart failure (\< 1 month) and half in chronic stable heart failure (no acute decompensation \< 3 month) chronic cardiac disease non ischemic ie: (Documented coronary angiogram showing non-significant CAD) cardiac insufficiency ie: (LV ejection fraction \< 45 %, or NYHA 2-4 or past history of clinical insufficiency decompensation) and No valvular etiology and No symptoms and no angina and Aged 18 to 75 years old Group 8
* Age and sex matched to the patients cohorts
* Lean (19kg/m² \< BMI \<25 kg/m²)
* Aged 18 to 75 years old
Exclusion Criteria
* \<18 or \>75 years old
* Past history of abdominal cancer+/- radiation therapy on the abdomen
* past history of intestinal resection except for appendicectomy
* Participants with acute or chronic inflammatory or infectious diseases (including VHC, VHB and HIV)
* Organ transplantation
* Patient on Immunosuppressive therapy
* Patients with severe kidney failure and or patients on dialysis therapy or eGFR \< 50 ml/min per 1.73 m2 body surface area)
* Non affiliated to social security
* Patients who do not understand the research procedures or those that are institutionalized, or those unable to give informed consent
* Patients who decline participation
* Patients with drug or alcohol addiction
* Recent lost of weight \>10 kilos in the past 3 months
* Recent antibiotic treatment (\<2months)
* Patients on non-steroid anti-inflammatory treatment for the past 48 hours
* Patients on laxative therapy that could modify the bowel transit in the past week
* Patients on therapy that can modify transit time (orlistat and acarbose)
* Pregnant women or breast feeding women
* Patients who are already included in a clinical study which implies testing any pharmaceutical drug. On the other hand, patients recruited in other observational studies can be recruited in METACARDIS
Group II : Obese
IIa:
Type 2 diabetic patients Past history of coronary syndrome Clinical signs of CAD
IIb:
Patients with previous bariatric surgery
Group III Past history of coronary syndrome Clinical signs of CAD Known auto-immune diabetes mellitus Patients with a HbA1c \> 10 % We will exclude secondary diabetes mellitus or type 1 or Idiopathic diabetes or Other specific types of diabetes Genetic defects of the β-cell or Genetic defects in insulin action or Diseases of the exocrine pancreas or Endocrinopathies or Drug- or chemical-induced diabetes or diabetes due to pancreatic resection
Group IV Past history of coronary syndrome Left ventricular dysfunction FeVG\<45%
Group V Left ventricular dysfunction FeVG\<45%
Group VII Significant documented CAD Past history of coronary syndrome
Group VIII Patients with known chronic inflammatory diseases Patients with either type 2 diabetes, cardiovascular diseases, Patients with treatment for dyslipidemia or for hypertension Patients with chronic inflammatory diseases, Patients with diseases of the gastrointestinal tract, including prior major abdominal surgery on the gastrointestinal tract Patients on non-steroid anti-inflammatory treatment or after a wash-up period of 2 days
* Past history of abdominal cancer+/- radiation therapy on the abdomen
* past history of intestinal resection except for appendicectomy
* Participants with acute or chronic inflammatory or infectious diseases (including VHC, VHB and HIV)
* Organ transplantation
* Patient on Immunosuppressive therapy
* Patients with severe kidney failure and or patients on dialysis therapy or eGFR \< 50 ml/min per 1.73 m2 body surface area)
* Non affiliated to social security
* Patients who do not understand the research procedures or those that are institutionalized, or those unable to give informed consent
* Patients who decline participation
* Patients with drug or alcohol addiction
* Recent lost of weight \>10 kilos in the past 3 months
* Recent antibiotic treatment (\<2months)
* Patients on non-steroid anti-inflammatory treatment for the past 48 hours
* Patients on laxative therapy that could modify the bowel transit in the past week
* Patients on therapy that can modify transit time (orlistat and acarbose)
* Pregnant women or breast feeding women
* Patients who are already included in a clinical study which implies testing any pharmaceutical drug. On the other hand, patients recruited in other observational studies can be recruited in METACARDIS
Group II : Obese
IIa:
Type 2 diabetic patients Past history of coronary syndrome Clinical signs of CAD
IIb:
Patients with previous bariatric surgery
Group III Past history of coronary syndrome Clinical signs of CAD Known auto-immune diabetes mellitus Patients with a HbA1c \> 10 % We will exclude secondary diabetes mellitus or type 1 or Idiopathic diabetes or Other specific types of diabetes Genetic defects of the β-cell or Genetic defects in insulin action or Diseases of the exocrine pancreas or Endocrinopathies or Drug- or chemical-induced diabetes or diabetes due to pancreatic resection
Group IV Past history of coronary syndrome Left ventricular dysfunction FeVG\<45%
Group V Left ventricular dysfunction FeVG\<45%
Group VII Significant documented CAD Past history of coronary syndrome
Group VIII Patients with known chronic inflammatory diseases Patients with either type 2 diabetes, cardiovascular diseases, Patients with treatment for dyslipidemia or for hypertension Patients with chronic inflammatory diseases, Patients with diseases of the gastrointestinal tract, including prior major abdominal surgery on the gastrointestinal tract Patients on non-steroid anti-inflammatory treatment or after a wash-up period of 2 days
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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European Union
OTHER
Sponsor Role
collaborator
Assistance Publique - Hôpitaux de Paris
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Karine Clement, Professor
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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University of Copenhagen
Copenhagen, , Denmark
Site Status
RECRUITING
Hôpital Pitié-Salpétrière
Paris, , France
Site Status
RECRUITING
University of Leipzig
Leipzig, , Germany
Site Status
RECRUITING
Countries
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Denmark
France
Germany
Central Contacts
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References
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Belda E, Voland L, Tremaroli V, Falony G, Adriouch S, Assmann KE, Prifti E, Aron-Wisnewsky J, Debedat J, Le Roy T, Nielsen T, Amouyal C, Andre S, Andreelli F, Bluher M, Chakaroun R, Chilloux J, Coelho LP, Dao MC, Das P, Fellahi S, Forslund S, Galleron N, Hansen TH, Holmes B, Ji B, Krogh Pedersen H, Le P, Le Chatelier E, Lewinter C, Manneras-Holm L, Marquet F, Myridakis A, Pelloux V, Pons N, Quinquis B, Rouault C, Roume H, Salem JE, Sokolovska N, Sondertoft NB, Touch S, Vieira-Silva S; MetaCardis Consortium; Galan P, Holst J, Gotze JP, Kober L, Vestergaard H, Hansen T, Hercberg S, Oppert JM, Nielsen J, Letunic I, Dumas ME, Stumvoll M, Pedersen OB, Bork P, Ehrlich SD, Zucker JD, Backhed F, Raes J, Clement K. Impairment of gut microbial biotin metabolism and host biotin status in severe obesity: effect of biotin and prebiotic supplementation on improved metabolism. Gut. 2022 Dec;71(12):2463-2480. doi: 10.1136/gutjnl-2021-325753. Epub 2022 Jan 11.
Reference Type
DERIVED
Other Identifiers
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IDRCB2013-A00189-36
Identifier Type: OTHER
Identifier Source: secondary_id
P121102
Identifier Type: -
Identifier Source: org_study_id