Combining minimally invasive endoscopic sleeve gastroplasty (ESG) with a weekly injection of the glucagon-like peptide-1 (GLP-1) agonist semaglutide (Ozempic, Novo Nordisk) results in considerably larger weight reduction than ESG alone in sufferers with diabetes and extra weight who usually are not candidates for bariatric surgery, new analysis reveals.
During minimally invasive ESG, a versatile endoscope outfitted with an endoscopic suturing system is inserted down the esophagus and into the abdomen. The endoscopist then applies the sutures to the higher portion of the abdomen, minimizing its measurement to limit the quantity of meals a affected person can ingest.
“Our stomachs can stretch again a bit, however we will use the suturing system once more,” defined the lead investigator of the analysis Anna Carolina Hoff, MD, founder and medical director of Angioskope Brazil, São José dos Campos.
“It’s vital that sufferers with diabetes lose as a lot weight as doable as a result of, in the event that they lose about 10% of their complete physique weight, they’ve a fantastic enchancment of their glycemic ranges, and a few sufferers may even cease taking their [antidiabetic] medicines,” Hoff instructed Medscape Medical News.
“And we discovered that by including the GLP-1 agonist [semaglutide], we may enhance weight reduction from, on common, about 16%-18% of complete physique weight with ESG alone to as much as 27%, so it is a fantastic metabolic mixture,” she famous.
Hoff introduced the findings throughout the digital Digestive Disease Week 2021 (DDW 2021).
Asked to remark, Scott Kahan, MD, MPH, director, National Center for Weight and Wellness, Milken Institute School of Public Health, George Washington University, Washington, DC, cautioned that it is nonetheless early days for minimally invasive ESG.
“It is cheap to imagine that the long-term outcomes [with ESG] will not be nearly as good or sturdy over time as with bariatric surgical procedure, however…we must see.”
However, “We know that, sometimes, mixtures of therapeutic choices work higher than a one-off possibility, so I believe the true good thing about this research — exterior the precise process and this particular medicine — is that it’s a very helpful proof-of-principle research displaying that mixtures do work higher,” Kahan instructed Medscape Medical News.
Minimally Invasive Endoscopic Sleeve Gastroplasty
ESG is a surrogate for laparoscopic sleeve gastrectomy that may supply the advantages of such a process to those that do not qualify for, or do not want to pursue, bariatric surgical procedure. It could be carried out at an earlier stage of illness, in these with a physique mass index (BMI) of 30 mg/kg2, whereas typically individuals are not provided bariatric procedures except they’ve a BMI ≥ 35 mg/kg2 with comorbidities or a BMI ≥ 40 mg/kg2 if they don’t have comorbidities.
Subcutaneous semaglutide is already accredited for the remedy of type 2 diabetes in adults at doses of as much as 1 mg/week; larger doses are wanted for weight reduction. Novo Nordisk has been investigating larger doses for weight reduction within the STEP trial program, which is now full, and the corporate has submitted the info to the US Food and Drug Administration and European Medicines Agency for an extra indication of adults with obesity (BMI ≥ 30 kg/m2) or who’re obese (BMI ≥ 27 kg/m2) and who’ve a minimum of one weight-related comorbidity, as an adjunct to a reduced-calorie weight loss plan and elevated bodily exercise, with a call anticipated quickly.
Novo Nordisk has additionally developed an oral type of semaglutide, which has been approved as a once-daily agent for type 2 diabetes (Rybelsus) in doses of seven mg and 14 mg to enhance glycemic management together with weight loss plan and train. It is the primary GLP-1 agonist accessible in pill kind.
Patients Lost Fat Mass as Well as Excess Weight
The Brazilian research concerned 58 sufferers with weight problems or obese who additionally had diabetes and had been present process minimally invasive ESG; they had been additional randomized to obtain semaglutide or placebo.
The GLP-1 agonist (or sham placebo) was initiated 1 month after members had undergone the process and sufferers had been monitored every month for weight reduction and sort of fats loss achieved with the mixture versus ESG alone. The preliminary dose of semaglutide used was 0.25 mg subcutaneous every week however could possibly be titrated as much as a most dose of 1.5 mg.
At the tip of 11 months of lively remedy versus placebo (12 months after ESG), sufferers who acquired further semaglutide misplaced 86.3% of their extra physique weight — the quantity of weight sufferers wanted to lose to achieve regular BMI — in contrast with solely 60.4% for ESG controls.
Specifically, the imply share complete physique weight reduction on the finish of 12 months was 25.2% for these within the mixture group in contrast with 18.6% for these handled with ESG alone (P < .001).
More importantly, sufferers within the mixture group misplaced 12.6% of their physique fats mass in comparison with 9% for ESG controls, whereas imply A1c ranges fell extra in these handled with further semaglutide in contrast with controls (P = .0394).
Indeed, 5 sufferers within the mixture group reverted to a nondiabetic state and had been capable of discontinue antidiabetic medicines altogether, Hoff famous.
“Our fundamental objective isn’t just to shed weight however to lose physique mass fats, which could be very completely different from simply reducing weight,” she defined.
If sufferers shed weight however nonetheless preserve a excessive share of physique fats mass, they’ve what she refers to as “sarcopenic weight problems” as a result of on this state sufferers have misplaced quite a lot of muscle mass however nonetheless have excessive ranges of metabolically lively visceral fats. Among many different inflammatory complexes, metabolically lively visceral fats accommodates a lot of inflammasomes, and it’s the latter which have been related to various obesity-related cancers.
“Obesity is a progressive illness, so what we are attempting to do right here is purchase time for sufferers so they don’t progress to [bariatric] surgical procedure, and this strategy provides sufferers an opportunity to behave earlier earlier than weight problems takes over and extra metabolic penalties happen,” she emphasised.
So, when mixed with semaglutide, “We now have a minimally invasive process that may be simply as profitable [as surgery] and which could be made accessible to much more individuals seeking to lose a big quantity of weight,” she concluded.
Hoff and Kahan have reported no related monetary relationships.
DDW 2021. Abstract Su548. Presented May 23, 2012.
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