Background
To date, surgeons and physicians have found positive results treating metabolic syndrome with surgical and non-surgical weight loss therapies. The purpose of this study was to evaluate changes in telomere length in patients with metabolic syndrome after weight loss.
Methods/design
This study is a three-arm randomized controlled trial. The first group is composed of patients who have undergone stapleless bypass surgery (one anastomosis gastric bypass with an obstructive stapleless pouch and anastomosis (LOAGB-OSPAN)). The second group of patients underwent standard gastric bypass surgery (laparoscopic mini-gastric bypass-one anastomosis gastric bypass (LMGB-OAGB). The patients in the third group received non-surgical weight loss therapy, including a hypocaloric diet with energy restriction (− 500 kcal/day).
The aim is to compare changes—telomere length, body mass index, comorbidities, and quality of life—in patients with metabolic syndrome after weight loss.
Discussion
To the best of our knowledge, this is the first randomized study to simultaneously compare the effects of surgical and non-surgical weight loss on changes in telomere length. It could provide a solution to the growing problem of metabolic syndrome. Normalization of the body mass index results in improvements in the health of patients with metabolic syndrome.
Trial registration
ClinicalTrials.gov,
NCT03667469
. Registered on 11 September 2018.
Electronic supplementary material
The online version of this article (10.1186/s13063-019-3304-9) contains supplementary material, which is available to authorized users.
Background
Laparoscopic one anastomosis gastric bypass (LOAGB) is a simple variation of gastric bypass and has gained worldwide popularity with clinical outcomes similar to laparoscopic Roux-en-Y gastric bypass (LRYGB) for weight loss and management of comorbidities. However, biliary reflux to the esophagus negates the benefits of LOAGB. In addition, weight gain after LOAGB and after LRYGB is a major problem in bariatric surgery.
The aim of this article is to describe the design and protocol of a randomized controlled trial comparing the outcomes of two methods of LOAGB: experimental method with wrapping versus standard method nonwrapping fundus of the excluded part of the stomach to prevent weight regain and biliary reflux after LOAGB.
Methods
The study was designed as a single-center prospective, interventional, randomized controlled trial. Masking: None (open label). Allocation: randomized. Enrollment: 100 obese patients. The relevant ethics committee approved the trial protocol.
The endpoints (body mass index, bile reflux in the esophagus, other reflux symptoms) will be assessed presurgery and postsurgery (12, 24, and 36 months postoperatively).
Discussion
With its 3-year follow-up time, this RCT will provide important data on the impact of wrapping the fundus of the excluded part of the stomach to prevent weight regain and biliary reflux after LOAGB.
Trial registration
ClinicalTrials.govNCT04834635. Registered on 8 April 2021.
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