Introduction
Obesity has reached pandemic proportions. According to the World Health Organization, 16% of the global adult population, or about 890 million people, have obesity(1). Intragastric balloon (IGB) is an alternative method to induce weight loss in subjects with obesity. However, not all subjects tolerate an IGB, and up to 15% of the cases, the IGB may be removed early due to intolerability(2). The factors that predict IGB tolerability remain poorly studied. In this study, we investigated whether there is an association between the baseline gastric emptying rate and IGB tolerability.
Aims & Methods
Twenty-eight subjects with a Body Mass Index (BMI) over 27.5 kg/m² were included. Orbera 365® IGBs were endoscopically inserted and filled with 550 ml saline solution and scheduled for removal after 12-months. Before insertion, the subjects underwent a standardized, FDA-approved 13C-Spirulina breath test to measure their gastric emptying half-time (T1/2). Gastrointestinal symptoms were assessed using the Gastrointestinal Symptom Rating Scale (GSRS) at baseline and at 4, 8, 16, and 24 weeks post-insertion, even after eventual early IGB removal.
Results
Six subjects had their IGBs removed earlier than planned due to tolerance issues, which we define as early removal. Early removal in our study refers to any removal that occurred before the planned 12-months. The specific timepoints of removal varied: one at four weeks, two at six months, one at eight months, and two at eleven months.
In the group that had their IGB removed earlier, the median baseline GSRS score was 28 (range 23-41), with a median T1/2 of 81.4 min (range 38.4-140.1). The median GSRS score at 4 weeks was 55.5 (range: 42-72), at 8 weeks 45 (range: 19-82), at 16 weeks 45.5 (range: 19-31), and at 24 weeks 37 (range 22-61).
In the group that tolerated the IGB, the median baseline GSRS score was 28 (range 19-77), with a median T1/2 of 61 min (range 34.5-108.4). The median GSRS score at 4 weeks was 53 (range: 24-133); at 8 weeks 37.5 (range: 19-79); at 16 weeks 37 (range: 21-85), and at 24 weeks 37 (range 19-104), respectively.
No statistically significant differences were observed in half-times (T1/2) and GSRS scores between the two groups at the examined time points. The p-value for T1/2 was 0.09. For GSRS, p-values were as follows: 0.89 at baseline, 0.63 at 4 weeks, 0.87 at 8 weeks, 0.45 at 16 weeks, and 0.73 at 24 weeks. Additionally, correlation analysis between GSRS scores and T1/2 values showed no significant relationships at baseline (p = 0.50), 4 weeks (p = 0.89), 8 weeks (p = 0.93), 16 weeks (p = 0.983), and 24 weeks (p = 0.86). These results suggest a consistent lack of significant association across all time points.
Conclusion
Early IGB removal cannot be predicted by the baseline gastric emptying rate or baseline GSRS in our study. The GSRS scores for subjects that tolerated the IGB, regardless of the time point, do not correlate with their baseline gastric emptying rate.
References
- World Health Organization. (2022). Obesity and overweight. Retrieved from https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight
- Jamal MH, Al-Kanawati N, ElAbd R, et al. A Study Examining the Orbera365 Intragastric Balloon Safety and Effects on Weight Loss. Obesity Surgery 2021: 31(12); 5342–5347. https://doi.org/10.1007/s11695-021-05729-8