Atherosclerosis vessel calcification
Conditions
Interventions
Patients will be treated with either allogenic or autologous microbial
transplantion by duodenal tube after bowel lavage.
Both the donor and the subject will deliver a fresh feces sample (150-250g o
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subjects: Kaukasian, adult, obese males with BMI >30 kg/m2 and metabolic syndrome, including increased fasting glucose Donors: healthy, adult, lean males (BMI 20-25 kg/m2) on a vegetarian diet
Exclusion criteria
Exclusion criteria: Supplement use (including vitamin/choline/carnitine supplements, energy drinks and carnitine-enriched soymilk); a medical history of a cardiovascular event (myocardial infarction or stroke) or cholecystectomy; use of medication including antacids and oral antibiotics in the past three months; (expected) prolonged compromised immunity (e.g. due to recent cytotoxic chemotherapy or HIV-infection with a CD4 count
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint concerns changes in postprandial choline and carnitine metabolism at baseline and 2 weeks after vegetarian microbial transplantation. We hypothesize that post-treatment changes are caused by altered gut microbiota composition. Thus fecal samples will be obtained for relating these changes. Changes in gut microbiota composition Morning stool samples will be collected at baseline, 1 and 2 weeks after start of the study to determine microbiota composition upon vegetarian microbial transplantation. Samples will be taken by collection on toilet paper or in a fecal container, to be directly frozen at -80 degrees C in the AMC. Fecal analysis will be done by HITChip array which is developed for exact and sensitive enumeration of bacterial population | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters We hypothesize that gut microbiota transplantation from lean vegetarian donors to obese recipients will lead to changes in choline and carnitine metabolism and subsequent decreases in arterial wall inflammation, in which both are mediated by altered intestinal microbiota. To determine whether and to what extent this trait is transmissible via gut microbiota transplantation, we will also perform a CCCT and PET/CT-scan within the lean group. As such, differences in plasma TMA/TMAO between lean donors and their recipients two weeks after treatment can be determined. Tertiary study parameters Third endpoint are changes in macrovascular (aortic + carotid wall) inflammation (changes in TBR signal of aortic arch and carotid arteries) by obtaining 18F-FDG PET/CT-scan images as previously described in metabolic syndrome subjects, a procedure which is routine at the AMC department of Vascular Medicine Fourth study parameters Subcutaneous adipose tissue biopsies will be performed before and two weeks after treatment. They will be analysed for inflammatory markers to determine associations between gut microbiota composition, choline and carnitine metabolism and subcutaneous adipose tissue inflammation. This way we can correlate changes in inflammation in various tissues from source (intestine) to target (subcutaneous fat) and relate these changes to choline and carnitine metabolism. | — |
Countries
Netherlands
Outcome results
None listed