parallel randomized trial
NCT05268627
Endoscopic Ultrasound Guided Gastric Botulinum Toxin Injections Versus Glucagon Like Peptide 1 Receptor Agonist in Weight Loss
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Botulinum toxin EUS guided gastric botulinum toxin A 100 U | lifestyle: standard | 20 | 20 | |
| A2 | Liraglutide maximum tolerated dose injection once daily Liraglutide up to 3 mg daily | lifestyle: standard | 20 | 20 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Botulinum toxin A1 | Liraglutide maximum tolerated dose injection once daily A2 |
|---|---|---|---|
| age | mean (years) | 36.45 | 37.15 |
| age | sd (years) | 8.33 | 12.28 |
| bmi | mean (kg/m2) | 40.53 | 44.15 |
| bmi | sd (kg/m2) | 4.41 | 5.94 |
| female | n | 18 | 16 |
| female | percent | 90 | 80 |
| other diabetes | n | 5 | 3 |
| other diabetes | percent | 25 | 15 |
| waist | mean (cm) | 115.45 | 114.05 |
| waist | sd (cm) | 9.95 | 11.67 |
| weight | mean (kg) | 107.30 | 123.28 |
| weight | sd (kg) | 11.41 | 17.17 |
Analyses this trial contributes to
- Serious adverse eventsOverweight or obesity without diabetes (adults); longest follow-up; descriptive only
- Serious adverse eventsOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- NauseaOverweight or obesity without diabetes (adults); longest follow-up; descriptive only
- NauseaOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- DiarrheaOverweight or obesity without diabetes (adults); longest follow-up; descriptive only
- DiarrheaOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
Results
8 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Percent body weight change (2 lines; O10)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 16 | A1 | percent change | -11.7 percent | 20 | not stated; randomized; R0006920:Table 2 | ||
| 16 | A2 | percent change | -10.9 percent | 20 | not stated; randomized; R0006920:Table 2 |
Serious adverse events (2 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | not stated; randomized; R0006920:Results | ||||
| A2 | events | 0 / 20 | not stated; randomized; R0006920:Results |
Nausea (2 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | not stated; randomized; R0006920:Results | ||||
| A2 | events | 1 / 20 | not stated; randomized; R0006920:Results |
Diarrhea (2 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | not stated; randomized; R0006920:Results | ||||
| A2 | events | 1 / 20 | not stated; randomized; R0006920:Results |