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Cardiometabolic DiseaseMETACARDISNCT02059538

Metagenomics and Integrative Systems Medicine of Cardiometabolic Diseases

A study testing Adipose tissue biopsies (omental and subcutaneous) liver, CT-scan and Stools sampling in people with Cardiometabolic Disease, run by Assistance Publique - Hôpitaux de Paris at 3 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Cardiometabolic Disease
What is being tested?
Adipose tissue biopsies (omental and subcutaneous) liver, CT-scan and Stools sampling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,350 participants
Where
3 sitesin 3 countries
Study dates
Jun 2013to Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • Definitive 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
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  • 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
  • Temporary exclusion criteria:
  • 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
  • Specific exclusion criteria per group Group I : Type-2 diabetic patients or patients on anti-diabetic agent Clinical signs of CAD Past history of coronary syndrome
  • 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

Trial locations and contacts

3 sites in 3 countries.

Karine Clement, Professor contact

0033(0) 1 4217 7928

karine.clement@psl.aphp.fr

3 sites in 3 countries

Denmark1 site, 1 recruiting

  • University of Copenhagen

    Copenhagen

    Oluf Borbye Pedersen

    Recruiting

Other trials in Denmark

France1 site, 1 recruiting

  • Hôpital Pitié-Salpétrière

    Paris, 75013

    Karine Clement, Professor

    Recruiting

Other trials in France

Germany1 site, 1 recruiting

  • University of Leipzig

    Leipzig

    Michael Stumvoll, Pr

    Recruiting

Other trials in Germany

About this study

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.

Read the detailed description

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.

Being tested
Adipose tissue biopsies (omental and subcutaneous) liver, CT-scan, Stools sampling, DNA sampling, Blood sampling
Keywords
Obesity, Type 2 diabetes, Coronary artery diseases, Microbiota, Omics (ie transcriptomics, metabolomics, metagenomics, lipidomics)
Medical subject headings
Obesity, Diabetes Mellitus, Type 2, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adipose tissue biopsies (omental and subcutaneous) liverOther

  • CT-scanRadiation

  • Stools samplingOther

  • DNA samplingOther

  • Blood samplingOther

  • Urine samplingOther

  • Dual energy X-ray absorptiometry-scan (DEXA-scan)Radiation

Study groups in NCT02059538
Study groupRoleWhat they receive
Group 1OtherMetabolic syndrome
Receives: Other: Adipose tissue biopsies (omental and subcutaneous) liver; Radiation: CT-scan; Other: Stools sampling; Other: DNA sampling; Other: Blood sampling; Other: Urine sampling; Radiation: Dual energy X-ray absorptiometry-scan (DEXA-scan)
Group 2OtherSeverly obese patients
Receives: Other: Adipose tissue biopsies (omental and subcutaneous) liver; Radiation: CT-scan; Other: Stools sampling; Other: DNA sampling; Other: Blood sampling; Other: Urine sampling; Radiation: Dual energy X-ray absorptiometry-scan (DEXA-scan)
Group 3OtherType-2 diabetics patients
Receives: Other: Adipose tissue biopsies (omental and subcutaneous) liver; Radiation: CT-scan; Other: Stools sampling; Other: DNA sampling; Other: Blood sampling; Other: Urine sampling; Radiation: Dual energy X-ray absorptiometry-scan (DEXA-scan)
Group 4OtherPatients with first recent (< 2 weeks) acute coronary syndrome (ACS)
Receives: Other: Adipose tissue biopsies (omental and subcutaneous) liver; Radiation: CT-scan; Other: Stools sampling; Other: DNA sampling; Other: Blood sampling; Other: Urine sampling; Radiation: Dual energy X-ray absorptiometry-scan (DEXA-scan)
Group 5OtherPatients with stable chronic coronary artery disease without heart failure
Receives: Other: Adipose tissue biopsies (omental and subcutaneous) liver; Radiation: CT-scan; Other: Stools sampling; Other: DNA sampling; Other: Blood sampling; Other: Urine sampling; Radiation: Dual energy X-ray absorptiometry-scan (DEXA-scan)
Group 6OtherPatients with ischemic systolic heart failure (CHF)
Receives: Other: Adipose tissue biopsies (omental and subcutaneous) liver; Radiation: CT-scan; Other: Stools sampling; Other: DNA sampling; Other: Blood sampling; Other: Urine sampling; Radiation: Dual energy X-ray absorptiometry-scan (DEXA-scan)
Group 7OtherPatients with non-ischemic chronic heart failure
Receives: Other: Adipose tissue biopsies (omental and subcutaneous) liver; Radiation: CT-scan; Other: Stools sampling; Other: DNA sampling; Other: Blood sampling; Other: Urine sampling; Radiation: Dual energy X-ray absorptiometry-scan (DEXA-scan)
Group 8OtherHealthy volunteers
Receives: Other: Stools sampling; Other: DNA sampling; Other: Blood sampling; Other: Urine sampling; Radiation: Dual energy X-ray absorptiometry-scan (DEXA-scan)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Look for differences in gut microbiota signatures using metagenomic approach in the 8 different groups

    Look for differences in gut microbiota signatures using metagenomic approach in the 8 different groups (metabolic syndrome, type 2 diabetes, obesity, acute coronary event, chronic coronaropathy with or without cardiac insufficiency, cardiac insufficiency without coronaropathy and controls), in order to uncover gut derived signature associated with CMD stages

    Measured: baseline

Secondary outcomes (1)

  1. Establish differences in fecal metabolomic signatures using 1H nuclear magnetic resonance (NMR) spectroscopy and Ultra-high Performance Liquid Chromatography Mass Spectrometry ((UPLC-MS) on fecal samples) in the 8 different groups (cf above mentioned)

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2014 (estimated)
  2. Study startJun 2013
  3. Primary completionJun 2015 (estimated)
  4. Study completionJun 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02059538
Sponsor's protocol ID
P121102
Other IDs
IDRCB2013-A00189-36
Acronym
METACARDIS
Status last verified
Jun 2013
First submitted
7 Nov 2013
Last updated
29 Aug 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 35017197

Questions about this trial

What is this clinical trial studying?

A study testing Adipose tissue biopsies (omental and subcutaneous) liver, CT-scan and Stools sampling in people with Cardiometabolic Disease, run by Assistance Publique - Hôpitaux de Paris at 3 sites in 3 countries.

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 36 inclusion and 31 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: status not confirmed, as of the sponsor's last update on 29 Aug 2014. 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 Denmark, France, Germany. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Karine Clement, Professor (0033(0) 1 4217 7928, karine.clement@psl.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Look for differences in gut microbiota signatures using metagenomic approach in the 8 different groups (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02059538, which also lists 1 linked publication.

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 29 Aug 2014.

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