Welcome to our weekly round-up of the latest bariatric and obesity-related papers published in the medical literature. As ever, we have looked far and wide to give you an overview of papers including liraglutide 3.0mg for weight recurrence post-RYGB, alcohol use disorders after bariatric surgery, protein-enhancing strategies are well tolerated by the majority of surgical participants, American Foregut Society publishes White Paper on mechanisms of pathologic reflux and antireflux surgery, liraglutide safe and effective in children, and more (please note, log-in maybe required to access the full paper).
A randomized, double-blind, placebo-controlled trial of weight loss using liraglutide 3.0mg for weight recurrence after Roux-en-Y gastric-bypass
Liraglutide is significantly more effective than placebo in treating weight recurrence that occurs post-RYGB without increased serious adverse events (SAE), researchers from the NYU Grossman School of Medicine, NY.
Published in SOARD, the investigators design this 56-week, double-blind, placebo-controlled study with 132 subjects, who achieved ≥25% TBWL status-post-RYGB and regained ≥10% TBWL after reaching nadir weight (NW). Patients were randomised to receive liraglutide3.0mg/day (n=89) or placebo (n=43) with lifestyle counselling regularly for 56 weeks.
The outcomes revealed 53.4% of the placebo group and 65% of the liraglutide group completed the trial due to SARS-COV2 pandemic. The change in %TBWL from baseline to 56-weeks was -8.8 (8.5, -29.2–9.7) and 1.1 (3.5, -7.9–5.99) in the liraglutide and placebo groups, respectively. In addition, 76% and 17% of subjects achieved ≥5% TBWL at 56 weeks in the liraglutide and placebo groups, respectively. 51% and 26.0% of the liraglutide group achieved ≥10% and ≥15% TBWL, respectively.
Interesting, none of the placebo group lost ≥10% TBWL. Twenty-one percent of subjects receiving liraglutide surpassed post-operative NW, whilst no subjects on placebo met this goal.
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Alcohol use disorders after bariatric surgery: a study using linked health claims and survey data
The number of people with with alcohol use disorders (AUDs) is concern and alcohol consumption should be restricted after surgery and patients should be closely monitored post-surgical care, according to investigators from the Leibniz Institute for Prevention Research and Epidemiology (BIPS), Bremen, Germany.
Writing in the International Journal of Obesity, 2151 bariatric surgery patients received a questionnaire, by which we assessed the presence of AUDs based on a validated instrument (AUDIT) as well as by ICD-10 codes from the health claims data.
The majority of patients were female (80.7%) with a median time since surgery of 6 years. Most patients had a RYGB-Bypass (50%) or sleeve gastrectomy (43%). Overall, 3% had at least one AUD diagnosis code in the claims data (men: 5.5%, women: 2.5%). Among men, 43.6% of diagnoses were coded after but not before the surgery (women: 52%). According to AUDIT (completed by 1496 patients), 9.4% of all patients showed at least hazardous/harmful alcohol consumption.
Interestingly, higher scores were associated with sex of the person, longer time since surgery and dissatisfaction with the weight loss.
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Protein Supplement Tolerability and Patient Satisfaction after Bariatric Surgery
Protein-enhancing strategies (PES) were tolerated by the majority of participants, and an improved protein intake with PES use was seen, according to researchers from The Netherlands.
Writing in Obesity Surgery, they compared five protein-enhancing strategies (PES) on patient tolerability, satisfaction and protein intake. In total 94 patients, scheduled for bariatric surgery, were enrolled and allocated to: (1) whey powder, (2) hydrolysed collagen powder, (3) plant-based powder, (4) protein-rich products, (5) protein gel or control.
The majority of patients (61%) did not experience dietary complaints from PES and could use PES ≥ 5 days of the week. PES non-usage was mainly related to taste dislike (58%). Hydrolysed collagen scored highest on tolerability and satisfaction: 86% of the participants could use HC ≥ 5 days and 71% were satisfied with the product. PES increased protein intake from 54.7 ± 21.5 g/day to 64.7 ± 23.4 g/day during the intervention (p=0.002), which differed from the control group (+ 10.1 ± 24.5 g/day vs. − 6.3 ± 23.8 g/day for controls, p=0.019). Whey showed the highest increase, namely + 18.3 ± 16.3 g/day (p=0.009).
However, the researchers noted that the taste of the products could be improved to further enhance satisfaction and tolerability.
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American Foregut Society Cooperative White Paper on Mechanisms of Pathologic Reflux and Antireflux Surgery
An antireflux barrier (ARB) Cooperative white paper, by the American Foregut Society, supports the concept of there being three major inter-related mechanisms promoting ARB competence: the LES as an intrinsic sphincter, the crural diaphragm as an extrinsic sphincter, and the gastroesophageal valve, a mechanical 1-way valve.
Writing in the American Foregut Society (AFS) tasked a 13-member working group of expert foregut surgeons and esophagologists (The ARB Cooperative) to develop a white paper on ARB function, dysfunction and mechanisms of action of antireflux surgery.
The ARB Cooperative concluded that factors contributing to ARB dysfunction include (1) separation of crural diaphragm from the lower esophageal sphincter with widening of the hiatus and diminished crural diaphragm sphincteric function; (2) loss of the intra-abdominal lower esophageal sphincter segment with complete disabling of the flap valve component of the ARB; (3) axial hiatal hernia leading to reflux during swallow-induced lower esophageal sphincter (LES) relaxation, LES hypotension, inspiration related reflux, a lowered threshold for eliciting transient LES relaxations, and increased compliance of the gastroesophageal junction leading to greater diameter of sphincter opening during transient LES relaxations.
They added that regarding antireflux surgery, the objectives include: (1) reduction of hiatal hernia and restoration of the intra-abdominal esophageal segment; (2) repair of the dilated hiatus; (3) restoring flap valve function by modifying gastroesophageal anatomy; and (4) restricting gastroesophageal junction opening during periods of relaxation.
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Liraglutide for Children 6 to <12 Years of Age with Obesity — A Randomized Trial
Among children (6 to <12 years of age) with obesity, treatment with liraglutide for 56 weeks plus lifestyle interventions resulted in a greater reduction in BMI than placebo plus lifestyle interventions, according to researcher writing on behalf of the for the SCALE Kids Trial Group.
Reporting in the New England Journal of Medicine, this phase 3a trial consisted of a 56-week treatment period and a 26-week follow-up period, they randomly assigned children (6 to <12 years of age) with obesity, in a 2:1 ratio, to receive either once-daily subcutaneous liraglutide at a dose of 3.0mg (or the maximum tolerated dose) or placebo, plus lifestyle interventions.
A total of 82 participants underwent randomisation with 56 were assigned to the liraglutide group and 26 to the placebo group. At week 56, the mean percentage change from baseline in BMI was −5.8% with liraglutide and 1.6% with placebo, representing an estimated difference of −7.4 percentage points (95% confidence interval [CI], −11.6 to −3.2; p<0.001). The mean percentage change in body weight was 1.6% with liraglutide and 10.0% with placebo, representing an estimated difference of −8.4 percentage points (p=0.001), and a reduction in BMI of at least 5% occurred in 46% of participants in the liraglutide group and in 9% of participants in the placebo group (p=0.02).
Adverse events occurred in 89% and 88% of participants in the liraglutide and placebo groups, respectively. Gastrointestinal adverse events were more common in the liraglutide group (80% vs. 54%); serious adverse events were reported in 12% and 8% of participants in the liraglutide and placebo groups, respectively.
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