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| Name | Class |
|---|---|
| Fondation Coeur et Recherche | UNKNOWN |
| ICAN Nutrition Education and Research | INDUSTRY |
| Fédération francaise de cardiologie | UNKNOWN |
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Statins are effective in cardio-vascular prevention by lowering LDL-Cholesterol levels but also through other mechanisms poorly understood. Our hypothesis is that some of these effects are mediated by microbiota alteration, leading to diminution of expression of microbiota derived pro-atherogenic metabolites.
The aim of this prospective double blind placebo-controlled study is to evaluate the acute effects of statins on microbiota and its derived metabolites at 2 and 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATORVASTATIN | Experimental | Atorvastatin 40mg caps: one daily. 3 patient visits: inclusion / week 2 / week 6. At each visit, blood sampling, stool sampling, ECG, to evaluate the pharmaco-metabolomic effects of the Statine |
|
| PLACEBO | Placebo Comparator | Placebo caps: one daily. 3 patient visits: inclusion / week 2 / week 6. At each visit, blood sampling, stool sampling, ECG to compare the pharmaco-metabolomic effects of the Statine between atorvastatin arm and placebo arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin 40mg Tablet | Drug | Patient participation for 6 weeks of treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of trimethylamine N-oxide trimethylamine oxide in blood, measured post-prandially at week-6 in atorvastatin arm and placebo arm. | The main objective of the study is to measure the direct effect of Hydroxy-methyl-glutaryl-coenzyme A reductase inhibitors (Atorvastatin) on the production of atherogenic metabolites derived from intestinal microbiota | Week-6 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of trimethylamine N-oxide trimethylamine oxide in blood, measured post-prandially at week-2 in atorvastatin arm and placebo arm. | To evaluate the evolution of the whole circulating metabolomic profile linked to the introduction of statins | week-2 |
| Rate of trimethylamine N-oxide trimethylamine oxide in blood, measured pre and post-prandially at week-2 and week-6 in atorvastatin arm. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joe Elie SALEM, MD | CIC 1421 CHU Pitie Salpetriere | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIC La Sapétrière | Paris | 75013 | France | |||
| CIC HEGP |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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2 groups of patients having treatment or placebo
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Placebo manufactured as the treatment. Packaging identical.
| Placebo comparator | Drug | Patient participation for 6 weeks of treatment |
|
|
To evaluate changes in the microbiome related to the introduction of statins |
| Week-2 and week-6 |
| Comparison between W0, W2 and W6 after initiation of atorvastatin vs placebo of circulating metabolomic profile (pre- and postprandial) | To correlate changes in lipid parameters induced by statins with metabolomic and lipidemic changes and microbiome. Rate of 100 metabolites will be analysed, and gathered as follows: metabolism of acylcarnitine (3), metabolism of bile acids (5), carbohydrate metabolism (1), dietary choline metabolism (3), metabolism of amino acids (34), vitamins and cofactors (7), metabolism of creatine (2), polyamine metabolism (3), purine metabolism (5), pyrimidine metabolism (9), tryptophan / kynurenine metabolism (21), caffeine metabolism (3), Citric Acid cycle (3), urea cycle (1) | Week 2 and Week 6 |
| Comparison between W0, W2 and W6 after initiation of atorvastatin vs placebo of the microbiome | To analyze the influence of the microbiota on the variability of response to atorvastatin. 169/5000 The stool will be analyzed by metagenomic sequencing using the "shot gun" technique, a direct sequencing that quantifies the number of bacterial genes and annotates them. | Week 2 and Week 6 |
| Paris |
| 75015 |
| France |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |