Metagenomics and Integrative Systems Medicine of Cardiometabolic Diseases
METACARDIS
2 other identifiers
interventional
2,350
3 countries
3
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2013
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 7, 2013
CompletedFirst Posted
Study publicly available on registry
February 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedAugust 29, 2014
June 1, 2013
2 years
November 7, 2013
August 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
baseline
Secondary Outcomes (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)
baseline
Other Outcomes (6)
Establish differences in systemic and adipose tissue inflammatory patterns (using multiplex array and adipose tissue transcriptomic) in the 8 above mentioned groups
Baseline
Establish host metabolomic differences in the 8 groups in order to obtain a CMD metabolomic derived signature (using 1H nuclear magnetic resonance) spectroscopy and Ultra-high Performance Liquid Chromatography Mass Spectrometry (in serum and urine)
Baseline
Establish a statistical association between host metabolomic signatures (cf above 3 in serum and urine) and the gut metagenomic signatures in the 8 groups
Baseline
- +3 more other outcomes
Study Arms (8)
Group 1
OTHERMetabolic syndrome
Group 2
OTHERSeverly obese patients
Group 3
OTHERType-2 diabetics patients
Group 4
OTHERPatients with first recent (\< 2 weeks) acute coronary syndrome (ACS)
Group 5
OTHERPatients with stable chronic coronary artery disease without heart failure
Group 6
OTHERPatients with ischemic systolic heart failure (CHF)
Group 7
OTHERPatients with non-ischemic chronic heart failure
Group 8
OTHERHealthy volunteers
Interventions
Eligibility Criteria
You may qualify if:
- 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
- +21 more criteria
You may not qualify if:
- \<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
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assistance Publique - Hôpitaux de Parislead
- European Unioncollaborator
Study Sites (3)
University of Copenhagen
Copenhagen, Denmark
Hôpital Pitié-Salpétrière
Paris, 75013, France
University of Leipzig
Leipzig, Germany
Related Publications (1)
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.
PMID: 35017197DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karine Clement, Professor
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2013
First Posted
February 11, 2014
Study Start
June 1, 2013
Primary Completion
June 1, 2015
Study Completion
June 1, 2016
Last Updated
August 29, 2014
Record last verified: 2013-06