跳至主要内容
临床试验/NCT02059538
NCT02059538Unknown不适用

Metagenomics and Integrative Systems Medicine of Cardiometabolic Diseases

Assistance Publique - Hôpitaux de Paris4 个研究点 分布在 3 个国家目标入组 2,350 人开始时间: 2013年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
2,350
试验地点
4
主要终点
Look for differences in gut microbiota signatures using metagenomic approach in the 8 different groups

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Group 1

Other

Metabolic syndrome

干预措施: Blood sampling (Other)

Group 1

Other

Metabolic syndrome

干预措施: Urine sampling (Other)

Group 1

Other

Metabolic syndrome

干预措施: Adipose tissue biopsies (omental and subcutaneous) liver (Other)

Group 2

Other

Severly obese patients

干预措施: Adipose tissue biopsies (omental and subcutaneous) liver (Other)

Group 2

Other

Severly obese patients

干预措施: CT-scan (Radiation)

Group 2

Other

Severly obese patients

干预措施: Stools sampling (Other)

Group 2

Other

Severly obese patients

干预措施: DNA sampling (Other)

Group 2

Other

Severly obese patients

干预措施: Blood sampling (Other)

Group 2

Other

Severly obese patients

干预措施: Urine sampling (Other)

Group 2

Other

Severly obese patients

干预措施: Dual energy X-ray absorptiometry-scan (DEXA-scan) (Radiation)

Group 7

Other

Patients with non-ischemic chronic heart failure

干预措施: Blood sampling (Other)

Group 7

Other

Patients with non-ischemic chronic heart failure

干预措施: Urine sampling (Other)

Group 7

Other

Patients with non-ischemic chronic heart failure

干预措施: Dual energy X-ray absorptiometry-scan (DEXA-scan) (Radiation)

Group 4

Other

Patients with first recent (< 2 weeks) acute coronary syndrome (ACS)

干预措施: Adipose tissue biopsies (omental and subcutaneous) liver (Other)

Group 6

Other

Patients with ischemic systolic heart failure (CHF)

干预措施: DNA sampling (Other)

Group 6

Other

Patients with ischemic systolic heart failure (CHF)

干预措施: Blood sampling (Other)

Group 6

Other

Patients with ischemic systolic heart failure (CHF)

干预措施: Urine sampling (Other)

Group 6

Other

Patients with ischemic systolic heart failure (CHF)

干预措施: Dual energy X-ray absorptiometry-scan (DEXA-scan) (Radiation)

Group 7

Other

Patients with non-ischemic chronic heart failure

干预措施: Adipose tissue biopsies (omental and subcutaneous) liver (Other)

Group 7

Other

Patients with non-ischemic chronic heart failure

干预措施: CT-scan (Radiation)

Group 7

Other

Patients with non-ischemic chronic heart failure

干预措施: Stools sampling (Other)

Group 7

Other

Patients with non-ischemic chronic heart failure

干预措施: DNA sampling (Other)

Group 8

Other

Healthy volunteers

干预措施: Stools sampling (Other)

Group 8

Other

Healthy volunteers

干预措施: DNA sampling (Other)

Group 8

Other

Healthy volunteers

干预措施: Blood sampling (Other)

Group 8

Other

Healthy volunteers

干预措施: Urine sampling (Other)

Group 8

Other

Healthy volunteers

干预措施: Dual energy X-ray absorptiometry-scan (DEXA-scan) (Radiation)

Group 3

Other

Type-2 diabetics patients

干预措施: Adipose tissue biopsies (omental and subcutaneous) liver (Other)

Group 3

Other

Type-2 diabetics patients

干预措施: CT-scan (Radiation)

Group 3

Other

Type-2 diabetics patients

干预措施: Stools sampling (Other)

Group 3

Other

Type-2 diabetics patients

干预措施: DNA sampling (Other)

Group 3

Other

Type-2 diabetics patients

干预措施: Blood sampling (Other)

Group 3

Other

Type-2 diabetics patients

干预措施: Urine sampling (Other)

Group 3

Other

Type-2 diabetics patients

干预措施: Dual energy X-ray absorptiometry-scan (DEXA-scan) (Radiation)

Group 1

Other

Metabolic syndrome

干预措施: Dual energy X-ray absorptiometry-scan (DEXA-scan) (Radiation)

Group 1

Other

Metabolic syndrome

干预措施: CT-scan (Radiation)

Group 1

Other

Metabolic syndrome

干预措施: Stools sampling (Other)

Group 1

Other

Metabolic syndrome

干预措施: DNA sampling (Other)

Group 4

Other

Patients with first recent (< 2 weeks) acute coronary syndrome (ACS)

干预措施: CT-scan (Radiation)

Group 4

Other

Patients with first recent (< 2 weeks) acute coronary syndrome (ACS)

干预措施: Stools sampling (Other)

Group 4

Other

Patients with first recent (< 2 weeks) acute coronary syndrome (ACS)

干预措施: DNA sampling (Other)

Group 4

Other

Patients with first recent (< 2 weeks) acute coronary syndrome (ACS)

干预措施: Blood sampling (Other)

Group 4

Other

Patients with first recent (< 2 weeks) acute coronary syndrome (ACS)

干预措施: Urine sampling (Other)

Group 4

Other

Patients with first recent (< 2 weeks) acute coronary syndrome (ACS)

干预措施: Dual energy X-ray absorptiometry-scan (DEXA-scan) (Radiation)

Group 5

Other

Patients with stable chronic coronary artery disease without heart failure

干预措施: Adipose tissue biopsies (omental and subcutaneous) liver (Other)

Group 5

Other

Patients with stable chronic coronary artery disease without heart failure

干预措施: CT-scan (Radiation)

Group 5

Other

Patients with stable chronic coronary artery disease without heart failure

干预措施: Stools sampling (Other)

Group 5

Other

Patients with stable chronic coronary artery disease without heart failure

干预措施: DNA sampling (Other)

Group 5

Other

Patients with stable chronic coronary artery disease without heart failure

干预措施: Blood sampling (Other)

Group 5

Other

Patients with stable chronic coronary artery disease without heart failure

干预措施: Urine sampling (Other)

Group 5

Other

Patients with stable chronic coronary artery disease without heart failure

干预措施: Dual energy X-ray absorptiometry-scan (DEXA-scan) (Radiation)

Group 6

Other

Patients with ischemic systolic heart failure (CHF)

干预措施: Adipose tissue biopsies (omental and subcutaneous) liver (Other)

Group 6

Other

Patients with ischemic systolic heart failure (CHF)

干预措施: CT-scan (Radiation)

Group 6

Other

Patients with ischemic systolic heart failure (CHF)

干预措施: Stools sampling (Other)

结局指标

主要结局

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

时间窗: baseline

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

Loading locations...

相似试验

Metagenomics and Integrative Systems Medicine of... | 临床试验