The aim of the current study is to determine the transport functionality, integrity, and viability in intestinal tissue obtained from patients who are expected to have a disturbed intestianl functionality due to severe obesity.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Onderzoek naar de functionaliteit en gezondheid van de dunne darm in mensen met obesitas.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study is to determine transport functionality,
integrity, and viability in each intestinal biopsy. The transport functionality
is shown as the ratio of transcellular to paracellular transport, also called
the Papp ratio (Papp = Apparent permeability rate). Permeability of
FITC-Dextran (4000 Dalton, FD4) determines intestinal integrity, and secretion
of lactate dehydrogenase (LDH) determines tissue viability.
Secondary outcome
In addition to these primary endpoints, processes that play an important role
in intestinal and overall health will also be measured in each biopsy. This
includes: 1) absorption and metabolism of foods and medicines, 2) (influencing)
intestinal permeability, 3) release of satiety hormones, 4) local immunological
reactions, and 5) interaction with the intestinal microbiome.
Background summary
Gut health has a major impact on human health. Processes that play an important
role in intestinal health are: 1) 1) absorption and metabolism of foods and
medicines, 2) (influencing) intestinal permeability, 3) release of satiety
hormones, 4) immunological reactions, and 5) interaction with the intestinal
microbiome. Most of these processes occur throughout the small and large
intestines, but the interaction with the microbiome is particularly important
in the large intestine. In addition to ingredients and medicines, people are
also orally exposed to various types of contaminants (e.g. microplastics),
which may have a negative effect. Understanding and investigating of these
processes in healthy and dysfunctional intestines is therefore of great
importance. For example, it can be used to test ingredients that contribute to
better intestinal health, for example in people with intestinal disorders.
Possible results may also contribute to adjusting drug dosages for patients in
a clinical setting. In addition, certain side effects caused, for example, by
drug-drug or drug-food interactions can be prevented.
Study objective
The aim of the current study is to determine the transport functionality,
integrity, and viability in intestinal tissue obtained from patients who are
expected to have a disturbed intestianl functionality due to severe obesity.
Study design
This is a cross-sectional cohort study in which patients undergo a Roux-en-Y
gastric bypass surgery. A biopsy of the jejunum will be collected during the
operation.
Study burden and risks
Previous research (BARICO study) has shown that the collection of a jejunum
biopsy does not entail any additional risks. Furthermore, there will be no
burden for the patients, as they do not have to undergo additional study
procedures.
wagnerlaan 55
Arnhem 6800TA
NL
wagnerlaan 55
Arnhem 6800TA
NL
Listed location countries
Age
Inclusion criteria
- Patients with the age of 18 or older
- BMI > 40 kg/m2
- BMI > 35 en < 40, with a obesity related comorbidity of which is suspected
that it improves after surgery induced weight loss.
Exclusion criteria
no exlcusion criteria
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL86051.091.23 |