Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 11, 2018
Open Peer Review Period: Jul 12, 2018 - Jul 26, 2018
Date Accepted: Mar 24, 2019
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Diet-Induced Alteration of Microbiota and Development of Obesity, Nonalcoholic Fatty Liver Disease, and Diabetes: Study Protocol of a Prospective Study
Background:
Development of obesity and obesity-related diseases, such as type 2 diabetes mellitus and nonalcoholic fatty liver disease (NAFLD), is associated with altered gut microbiota composition. The aim of this study is to investigate associations among dietary compounds, intestinal cell function, and gut microbiota composition. We hypothesize that dietary lipid intake is associated with Paneth cell and goblet cell properties that affect gut microbiota composition.
Objective:
The primary objective of this study is to determine whether a difference in dietary intake is associated with a difference in intestinal mucin-2 expression and gut microbiota composition.
Methods:
This is a single-center prospective study, including 1 obese group undergoing laparoscopic Roux-en-y gastric bypass and 2 lean control groups undergoing either laparoscopic cholecystectomy or upper gastrointestinal endoscopy (n=228). During laparoscopy, biopsies will be taken of visceral fat (omentum majus), liver, muscle tissue of the abdominal wall, and subcutaneous fat. In the obese group, a small segment of the jejunum will be collected for analysis, which will be compared with an endoscopically derived jejunal biopsy from the upper gastrointestinal endoscopy control group. Stool samples for microbiota profiling will be collected at baseline and 1 year after surgery. Primary outcomes are fecal microbiota composition and mucus characteristics. Secondary outcomes include Paneth cell phenotype, body weight, diet composition, glucose tolerance, resolution of comorbidities, and weight loss 1 year after surgery.
Results:
This trial is currently open for recruitment. The anticipated completion date is December 2019.
Conclusions:
The Diet-Induced Alteration of Microbiota and Development of Obesity, NAFLD, and Diabetes study will improve insight into the pathophysiology of obesity and its associated metabolic disorders. Better understanding of weight loss failure and weight regain following bariatric surgery might also behold new therapeutic opportunities for obesity and obesity-related comorbidities.
ClinicalTrial:
Netherlands Trial Register NTR5660; https://www.trialregister.nl/trial/5540 (Archived by WebCite at http://www.webcitation.org/78l7jOZre)
International Registered Report:
DERR1-10.2196/11553
Citation
Per the author's request the PDF is not available.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.