Obesity
Conditions
Brief summary
The aim of this study is to compare the 1-year total body weight loss outcomes for Class 1 and Class 2 Obesity patients who have undergone endoscopic sleeve gastroplasty (ESG) in contrast to medical treatment with glucagon-like peptide-1 (GLP-1) analogues.
Detailed description
Endoscopic sleeve gastroplasty (ESG) was developed with the aim of emulating the successful outcomes observed with sleeve gastrectomy, while obviating the need to permanently remove a large portion of the stomach. The recent MERIT trial reported that the estimated total body weight loss after ESG at 1-year was 13.6%, demonstrating superiority over lifestyle modifications alone. Glucagon-like peptide-1 (GLP-1) analogues such as liraglutide or semaglutide are currently approved for the treatment of obesity and type 2 diabetes mellitus. Evidence supports the use of these medications in weight loss. The total body weight loss from GLP-1 analogues reportedly range between 7.8-13.8%. As such, for patients with type 1 or 2 obesity who may not be candidates for bariatric surgery, the reported total body weight loss attainable by ESG and GLP-1 analogues appear comparable. In this study, patients eligible and consented for ESG will be retrospectively matched against a group of patients who were previously placed on GLP-1 analogue treatment for class 1 and 2 obesity. The primary outcome of the study will be total body weight loss at 1-year. We will also examine the short-term weight loss outcomes, metabolic outcomes, as well as healthcare costs between the 2 groups. Our hypothesis is that ESG will be non-inferior to GLP-1 analogues in weight loss and metabolic outcomes, with reduced healthcare costs, given the avoidance of repeated dosing.
Interventions
PROCEDUREEndoscopic sleeve gastroplasty
Endoscopic sleeve gastroplasty
Sponsors
Sengkang General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with classes 1 (BMI 27.5 to 34.9) and 2 (BMI 35 to 39.9) obesity in accordance with the World Health Organisation recommendations but modified to the interventional thresholds recommended for Asian populations
Exclusion criteria
* Patients with class 3 obesity and above (BMI \> 40.0) * Patients with contraindications to GLP-1 analogues * Patients with contraindications to endoscopic sleeve gastroplasty * Patients with previous bariatric or upper gastrointestinal surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total body weight loss | 1-year | Percentage total body weight loss |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short-term weight loss | 3-months | Percentage total body weight loss |
| Healthcare costs | 1-year | Patient costs associated with procedure, hospital stay, outpatient visits and pharmacological treatment |
| Metabolic outcomes | 3-months, 6-months, 9-months, 12-months | HbA1c values |
Countries
Singapore
Outcome results
None listed