Stapleless vs Stapled Gastric Bypass vs Hypocaloric Diet: a Three-Arm Randomized Controlled Trial of Body Mass Evolution with Secondary Outcomes for Telomere Length and Metabolic Syndrome Changes.

BACKGROUND: Obesity and metabolic syndrome (MetS) reduce life expectancy and are challenging to resolve. This randomized controlled trial (RCT) of patients with obesity and MetS undergoing surgical vs nonsurgical treatment compared changes in BMI, and secondarily, telomere length (as a biomarker of life expectancy) and changes in MetS components (insulin resistance, dyslipidemia, hypertension). METHODS: Study design was a single-center, prospective, three-arm RCT. Group 1 patients underwent novel unstapled laparoscopic one anastomosis gastric bypass with an obstructive stapleless pouch and anastomosis (LOAGB-OSPAN); Group 2, stapled laparoscopic mini-gastric bypass-one anastomosis gastric bypass (LMGB-OAGB); and Group 3, nonsurgical weight loss therapy via a hypocaloric diet with energy restriction (HDER). The primary outcome measure was change in BMI; secondary outcome measures included change in leukocyte telomere length and other MetS components. RESULTS: Of 96 participants screened, 60 were randomly allocated to 3 groups: LOAGB-OSPAN group (n = 20), LMGB-OAGB group (n = 20), and HDER group (n = 20). At post-treatment month 12, respective BMI changes: BMI -12.13 (-8.34, -15.93); -16.04 (-11.7, 20.37); -2,76 (-3.84, -9.36) (p < 0.01). The two surgical groups experienced significant change in telomere length: LOAGB-OSPAN 2.02 (1.61, 2.41), p = 0.001; LMGB-OAGB 2.07 (1.72, 2.43), p = 0.001; and HDER 0.28 (0.22, 0.78), p = 0.26. The surgical groups were also more effective in treating MetS components. There were no deaths. Adverse events: LOAGB-OSPAN (n = 2) (Clavien-Dindo grade II); LMGB-OAGB (n = 8) (grade I (n = 6) and grade II (n = 2). CONCLUSIONS: Compared with hypocaloric diet therapy, both bariatric procedures resulted in greater BMI loss, and secondarily, a significant increase in telomere length, and greater MetS resolution. TRIAL REGISTRATION: ClinicalTrials.gov , NCT03667469, registered on 11 September 2018.

Correction to: The life expectancy of patients with metabolic syndrome after weight loss: study protocol for a randomized clinical trial (LIFEXPE-RT).

Following publication of the original article [1], the authors notified us of a typing error in spelling Dr. Yeleuov's name. The original publication has been corrected.

Laparoscopic One-Anastomosis Gastric Bypass with Band-Separated Gastric Pouch (OAGB-BSGP): a Randomized Controlled Trial.

BACKGROUND: One-anastomosis gastric bypass with band-separated gastric pouch (OAGB-BSGP) is a novel "staplerless" version of OAGB. This randomized controlled trial (RCT) compared 2-year outcomes for OAGB-BSGP and standard OAGB. METHODS: The parallel-group RCT randomly allocated patients to group A, staplerless OAGB-BSGP, or group B, stapled OAGB. RESULTS: Respective mean values for groups A and B (n = 40 each): baseline body mass index (BMI, kg/m2), 40.6 ± 5.6 vs 41.2 ± 6.4 (p = 0.64); abdominal bleeding (mL), 5.9 ± 8.0 vs 31.1 ± 30.5 (p < 0.0001). Two-year outcomes: BMI, 26.3 ± 3.2 vs 29.0 ± 4.7; %TWL, 34.1 ± 9.0 vs 29.3 ± 10.6, p < 0.03; %EBMIL, 94.3 ± 23.6 vs 77.9 ± 29.3, p < 0.007; bile reflux, n = 1 (2.5%) vs n = 7 (17.5%) (p = 0.05); revisions, n = 0 vs n = 4 (10.0%), p = 0.12. CONCLUSIONS: At 2-year RCT follow-up, staplerless OAGB-BSGP patients had fewer complications, no revisions, and greater weight loss than stapled OAGB patients. TRIAL REGISTRATION: ISRCTN56106651 (OSPAN-RCT).

The life expectancy of patients with metabolic syndrome after weight loss: study protocol for a randomized clinical trial (LIFEXPE-RT).

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.