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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05872932
• Other study ID #: 2023-15/03/1374
• Status: Recruiting
• Phase: Phase 4
• Start date: December 30, 2023
• Est. completion date: July 2024

Study information

• Verified date: January 2024
• Source: Yuzuncu Yil University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 yet could not lose weight.

3. 18-65 years old patients

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 repetitive implantations.

Related Conditions & MeSH terms

• Obesity

Intervention

Procedure:
• gastric balloon implantation
After diagnostic endoscopy if there is no any gastric pathology that would be contraindication for balloon placement a gastric balloon will be placed
• botulinum toxin A injection
After diagnostic endoscopy if there is no any gastric pathology that would be contraindication Botox injection and balloon placement, 200 U of Botox A will be injected to antrum and fundus. And 1 week later gastric balloon will be implanted

Locations

Country	Name	City	State
Turkey	Yuzuncu Yil University Faculty of Medicine	Van

Sponsors (1)

Lead Sponsor	Collaborator
Sebahattin Celik MD

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who develop intolerance and undergo balloon removal procedure	Number of patients who develop intolerance and undergo balloon removal procedure	First 6 months after intragastric balloon placement
Primary	Quality of life measured using SF-36 questionnaire	The acute(1 week) time frame format of Short Form-36 questionnaire will be used to assess health-related quality of life	The questionnaire will be taken 1 week after the balloon placement
Primary	Nausea-vomiting and retching measured using Rhodes index of nausea-vomiting-retching(RINVR)		The questionnaire will be taken 6 hours after intragastric balloon placement
Primary	Number of analgesics and muscle relaxants needed		First week after intragastric balloon placement
Primary	Weight loss		6 months after intragastric balloon placement