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The immune system and microbial tone in relation to NAFLD/NASH before and after BARIatric surgery in the morbidly obese in Amsterdam; the BARIA cohort study.


- candidate number24632
- NTR NumberNTR5992
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-jul-2016
- Secondary IDsMETC 2015_357 
- Public TitleThe immune system and microbial tone in relation to NAFLD/NASH before and after BARIatric surgery in the morbidly obese in Amsterdam; the BARIA cohort study.
- Scientific TitleThe immune system and microbial tone in relation to NAFLD/NASH before and after BARIatric surgery in the morbidly obese in Amsterdam; the BARIA cohort study.
- ACRONYMBARIA
- hypothesis It is increasingly recognized that the immune system is a major player in this obesity related disease and the switch from benign to malign (insulin resistance and DM2) obesity is associated with changes in the immune system . In this regard, animal studies have suggested that the intestinal microbiome is thought to play a major role in driving these immunological and metabolites changes. However, at this moment it is unknown whether and to what extend intestinal microbiota and immunological tone can predict metabolic response (improvement in insulin sensitivity and weightloss) upon bariatric surgery. Increased understanding of the pathophysiological mechanism as well as their relationship to metabolic disturbances are thought to be of crucial importance to discover new diagnostic and therapeutical targets in obesity associated insulin resistance and NAFLD/NASH. Moreover, this study will identify the underlying pathophysiological mechanisms in subjects that will have NAFLD/NASH reduction upon the surgery (responders) and those that have no beneficial effect on at all (non-responders). This might help to predict who will benefit from the surgical intervention and in whom this is not effective.
- Healt Condition(s) or Problem(s) studiedObesity, Bariatric surgery
- Inclusion criteria- Scheduled for bariatric surgery
- Ability to provide informed consent
- No more than 5% weight loss in 6 months prior to surgery
- No more than 3% weight loss in 1 month prior to surgery
- Exclusion criteria- Known genetic basis for insulin resistance or glucose intolerance
- All medical and psychiatric conditions except for obesity related diseases.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-apr-2016
- planned closingdate
- Target number of participants1500
- Interventionsbariatric surgery
- Primary outcomeTo identify microbial, immunological and metabolic markers associated with weightloss after bariatric surgery. To this end, we will collect before, during surgery and after 2 years follow up.
- Secondary outcomeTo apply systems biology approach to identify hierarchy of driving mechanisms (microbial, immunological and metabolic markers) in relation to diet and satiety involved in the long term beneficial weight loss effects of bariatric surgery that can be used for personalised medicine
- Timepoints0,1,2,12 and 24 months
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. PhD. M. Nieuwdorp
- CONTACT for SCIENTIFIC QUERIESMD. PhD. M. Nieuwdorp
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD13-jul-2016 - 26-sep-2016


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