Outcome of Combined Botulinum Toxin A Injection and Gastric Balloon Implantation in Obesity Treatment

Last updated: January 18, 2025
Sponsor: Sebahattin Celik MD
Overall Status: Completed

Phase

2/3

Condition

Obesity

Diabetes Prevention

Treatment

botulinum toxin A injection

gastric balloon implantation

Clinical Study ID

NCT05872932
2023-15/03/1374
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Obesity, which is defined as the accumulation of fat in the body to a degree that impairs health, is defined as a serious public health problem and it is estimated that 13% (approximately 650 million) of the entire world population is obese.

There are different methods in the fight against obesity, one of these methods is bariatric interventions. Although bariatric surgery is the most effective of these procedures, the tendency to endoscopic methods is increasing due to the surgical risk. Gastric balloon is the most common endoscopic method. In addition, gastric botox is among the methods used.

Health consequences of endoscopic interventions have been widely investigating and while gastric balloon recommended as safe and effective method, the situation for gastric botox is controversial.

Although it seems as gastric balloon is an office procedure and safely performed, especially the first week is difficult process for patients. It can also end with abdominal pain, nausea, retching, and eventually a process leading to premature removal of the balloon. In Italian study, Genco et al. reported that out of 2515 patients 11 patients (0.44%) balloon removed due to psychological intolerance. While the reported rate of early gastric balloon removal generally ranges from 0.44% to 16%, De Castro ML. et al. reported the early removal rate as 20%. While the complications related to the gastric balloon are as stated, problems such as nausea, vomiting and cramps after the gastric botox procedure are either not reported or not seen at all.

Therefore, we hypothesize that sequential endoscopic procedures (first botox application followed by gastric balloon placement) will reduce these early complications (abdominal pain, nausea, retching) and early removal of the gastric balloon.

The only study we have reached regarding combined therapy was done in Turkey. Kanlıöz M et al. reported that combining botox and balloon was found to be more effective in losing weight, but it was stated that it had more side effects. In this study, we think that the side effects may already be related to the balloon. As James A et al. stated in their experimental work, the effectiveness of botox is time dependent. It has been stated that the efficacy is optimal after 6 hours in injections to the pyloric region.The fact that the balloon was inserted in the same session, without waiting for enough time after the botox procedure to be effective, may have reduced the possible protective effect of the botox.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. patients with body mass index over 30

  2. patients who have been on a diet and have done sports at least for 6 month and yetcould not lose weight.

  3. 18-65 years old patients

Exclusion

Exclusion Criteria:

  1. patients diagnosed with peptic ulcer

  2. untraceable patients after injection of botulinum toxin A

  3. patients with no history of bariatric surgery or interventions

  4. patients who do not retrieve balloon after 6 month or require repetitiveimplantations.

Study Design

Total Participants: 131
Treatment Group(s): 2
Primary Treatment: botulinum toxin A injection
Phase: 2/3
Study Start date:
December 30, 2023
Estimated Completion Date:
December 30, 2024

Connect with a study center

  • Yuzuncu Yil University Faculty of Medicine

    Van, 65080
    Turkey

    Site Not Available

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