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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Oct 10, 2018
Open Peer Review Period: Oct 14, 2018 - Oct 19, 2018
Date Accepted: Dec 9, 2018
(closed for review but you can still tweet)

The final, peer-reviewed published version of this preprint can be found here:

The Feasibility of Examining the Effects of Gastric Bypass Surgery on Intestinal Metabolism: Prospective, Longitudinal Mechanistic Clinical Trial

Courcoulas A, Stefater M, Shirley E, Gourash W, Stylopoulos N

The Feasibility of Examining the Effects of Gastric Bypass Surgery on Intestinal Metabolism: Prospective, Longitudinal Mechanistic Clinical Trial

JMIR Res Protoc 2019;8(1):e12459

DOI: 10.2196/12459

PMID: 30679147

PMCID: 6483060

Feasibility Of A Prospective Longitudinal Mechanistic Clinical Trial Aiming To Examine The Effects Of Gastric Bypass Surgery On Intestinal Metabolism

  • Anita Courcoulas; 
  • Margaret Stefater; 
  • Eleanor Shirley; 
  • William Gourash; 
  • Nicholas Stylopoulos

ABSTRACT

Background:

Current evidence shows that bariatric surgery and especially Roux-en-Y Gastric Bypass (RYGB) is the best treatment for obesity and its complications including type 2 diabetes (T2DM). Understanding the specific mechanisms responsible for the beneficial metabolic effects will help to engineer ways to improve the procedure or produce these effects without surgery.

Objective:

The focus of this report is a translational study, designed to test a hypothesis for the mechanisms underlying the improvement in T2DM following gastric bypass that involves specific changes in the post-surgical, short- and long-term metabolism and morphology of the jejunum (Roux limb). Specifically to test whether the intestine enhances its metabolism and activity after gastric bypass and increases its fuel utilization, we designed a prospective, longitudinal study, which involved the recruitment of bariatric bypass surgery candidates with and without T2DM. We describe the tissue bank that we have generated and we discuss in detail our experience, hoping to further facilitate the performance of longitudinal mechanistic studies in human patients undergoing bariatric surgery and especially those involving methods examining the post-bypass intestinal biology.

Methods:

We designed and conducted a clinical trial (clinicaltrials.gov ID NCT02710370) aiming to characterize the effects of RYGB on intestinal metabolism. Intestinal tissue samples were collected from the jejunum at surgery, 1, 6, and 12 months post operatively for analysis of intestinal gene expression, metabolomic and morphologic changes. The target number of patients with completed at least the 6-month follow up was 26 and we included a 20% attrition rate increasing the total number to 32.

Results:

To enroll 26 patients, we had to approach 79 potential participants. 37 agreed to participate and started the study. 33 active participants completed their 1 month, 30 their 6 month and 26 their 12 month studies. Three participants withdrew and 30 participants are still active. Altruism and interest in research were the most common reasons for participation. Important factors for feasibility and successful retention included: 1) large volume case flow, 2) inclusion and exclusion criteria broad enough to capture a large segment of the patient population, but narrow enough to ensure completing study aims and protecting safety concerns, 3) accurate assessment of willingness and motivation to participate in a study, 4) seamless integration of the recruitment process into normal clinical flow, 5) financial reimbursement and non-financial rewards and gestures of appreciation and 6) non-burdensome follow-up visits and measures and reasonable time allotted.

Conclusions:

Human translational studies of the intestinal mechanisms of metabolic and weight change after bariatric surgery are both important and feasible. A tissue bank with unique samples has been established that could be used by investigators in many research fields further enabling mechanistic studies on the effects of bariatric surgery. Clinical Trial: Clinicaltrials.gov ID NCT02710370


 Citation

Please cite as:

Courcoulas A, Stefater M, Shirley E, Gourash W, Stylopoulos N

The Feasibility of Examining the Effects of Gastric Bypass Surgery on Intestinal Metabolism: Prospective, Longitudinal Mechanistic Clinical Trial

JMIR Res Protoc 2019;8(1):e12459

DOI: 10.2196/12459

PMID: 30679147

PMCID: 6483060

Per the author's request the PDF is not available.

© 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.