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The role of the Gut Microbiota and Platelets in Postprandial Inflammation: the PPI Study

The role of the Gut Microbiota and Platelets in Postprandial Inflammation: the PPI Study - PPI

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43287
Enrollment
20
Registered
2016-10-07
Start date
2017-01-23
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

insulin resistance metabolic syndrome

Interventions

Subjects will receive oral vancomycin 500 mg 4 times a day for 7 days.
Gut microbiota
inflammation
platelets.
postprandial period

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Metabolic syndrome patients: * Caucasian male * BMI *30 kg/m2 * At least 2 of the following criteria: o fasting plasma glucose *5.6 mmol/L o waist-circumference *102 cm o HDL-cholesterol *1.02 mmol/L o Blood pressure *130/85 mmHg o HOMA-IR index *2.5 (HOMA-IR is measured as (fasting insulin (pmol/L) x fasting glucose (mmol/L)) / 135) * Triglycerides *1.7 mmol/L * Subjects should be able to give informed consent;Healthy controls: * Caucasian male * BMI 18,5-25 kg/m2 * HOMA-IR index *2.0 * Subjects should be able to give informed consent

Exclusion criteria

Exclusion criteria: Metabolic syndrome patients: * A history of cardiovascular event (CVI, MI) or pacemaker implantation * Use of any medication including PPI and antibiotics in the past three months or during the study period * (Expected) prolonged compromised immunity (due to recent cytotoxic chemotherapy or HIV infection with a CD4 count 5 units of alcohol daily or use of alcohol during the study period * History of cholecystectomy;Healthy controls: * A history of cardiovascular event (CVI, MI) or pacemaker implantation * Use of any medication including PPI and antibiotics in the past three months or during the study period * (Expected) prolonged compromised immunity (due to recent cytotoxic chemotherapy or HIV infection with a CD4 count 5 units of alcohol daily or use of alcohol during the study period * History of cholecystectomy

Design outcomes

Primary

MeasureTime frame
To investigate the effect of oral vancomycin in lean versus obese, insulin resistant subjects on postprandial bacterial translocation, as measured by plasma LPS, LBP and sCD14 as well as 16S DNA concentrations in whole blood, isolated platelets and isolated monocytes.

Secondary

MeasureTime frame
To investigate postprandial platelet activation, as measured by P-selectin expression and platelet-monocyte interaction in flow cytometric analyses. All measurements will be related to postprandial inflammation, as measured by monocyte phenotyping using flow cytrometric and histopathological analyses and plasma cytokine concentrations, and gut microbiota composition before and after treatment with oral vancomycin. Moreover, we will assess postprandial concentrations of plasma bile acids, FGF-19 and glucagon-like peptide 1 (GLP-1). Finally, we will determine the effect of oral vancomycin on satiety as measured by time taken to eat a standardized meal and intestinal transit time as measured by 24 hour Sitzmark capsule clearance.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)