Multicentre ESG Randomised Interventional Trial - MERIT
Contribution To Literature:
The MERIT trial showed that endoscopic sleeve gastroplasty (ESG) results in sustained weight loss.
Description:
The goal of the trial was to evaluate ESG compared with control among obese individuals.
Study Design
- Randomization
- Parallel
- Stratification
Obese subjects were randomized to ESG plus lifestyle modification (n = 85) versus lifestyle modification alone (n = 124). Lifestyle modification included a low-calorie diet and physical activity.
After 12 months, subjects in the ESG group could receive re-tightening based on initial suboptimal response. Subjects in the control group could cross over to ESG if they did not reach the primary target weight loss.
- Total number of enrollees: 209
- Duration of follow-up: 12 months
- Mean patient age: 46 years
- Percentage female: 84%
- Percentage with diabetics: 33%
Inclusion criteria:
- Obesity (body mass index 30 to <40 kg/m2)
- Patients 21–65 years of age
- History of failure of nonsurgical weight loss methods
Exclusion criteria:
- Gastrointestinal surgery
- Gastrointestinal tract inflammatory disease
Principal Findings:
The primary outcome, mean percentage of excess weight loss at 52 weeks, was 49.2% in the ESG group versus 3.2% in the control group (p < 0.0001).
Secondary outcomes:
- Mean percentage of total bodyweight loss at 52 weeks: 13.6% in the ESG group versus 0.8% in the control group (p < 0.0001)
- Achieving ≥25% of excess weight loss at 52 weeks: 77% in the ESG group versus 12% in the control group
- Improvement in 1 or more metabolic comorbidities at 52 weeks: 80% in the ESG versus 45% in the control group
Interpretation:
Among obese individuals, ESG resulted in significant and sustained weight loss at 52 weeks compared with control. Weight loss was sustained at 104 weeks. ESG is a minimally invasive procedure, which uses endoscopic suturing to imbricate most of the stomach. ESG also resulted in improvement in metabolic comorbidities. ESG can be considered a synergistic weight loss intervention among obese individuals.
References:
Dayyeh BK, Bazerbachi F, Vargas EJ, et al. Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial. Lancet 2022;400:441-51.
Clinical Topics: Cardiovascular Care Team, Diabetes and Cardiometabolic Disease, Prevention, Diet, Exercise
Keywords: Body Mass Index, Caloric Restriction, Comorbidity, Exercise, Gastroplasty, Life Style, Metabolic Syndrome, Obesity, Primary Prevention, Minimally Invasive Surgical Procedures, Weight Loss
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