Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04948177 |
| Other study ID # |
56665618-204.01.07A |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2019 |
| Est. completion date |
June 1, 2021 |
Study information
| Verified date |
June 2021 |
| Source |
Okan University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Newly, botulinum toxin A application into the stomach has been proposed as a treatment method
in obesity. It impacts through acetylcholine receptors located in smooth muscle cells and
suppresses stomach motility. This method aims to decrease gastric emptying time and thus to
extend the duration of feeling full. This effect of intragastric botulinum toxin A injection
(GBI) makes it easier to adhere to dietary prescriptions, which is the cornerstone of any
obesity treatment method.
Endoscopic inspections and the complicatedness in literature results, cases that have not
succeeded in losing weight after GBI might have pylorus contractility problems. Any
deterioration in pylorus activity is recognized to have the potential to influence gastric
emptying. In such a case, gastric emptying time would also be altered due to the paralysis of
pylorus muscles, which is one of the effect mechanisms of botulinum toxin A.
The pyloric orifice structure may have a crucial role in the success or failure of GBI
therapy for obesity treatment.
Description:
The prevalence of obesity has doubled globally in the last four decades to the extent that
nearly one-third of the world population is now classified as overweight/obese. Obesity
causes adverse impacts on almost every physiological system in the human body and comprises
an important public health problem. It is associated with an increased risk of many
developing co-morbid conditions, such as diabetes mellitus, cardiovascular disease, several
types of cancers, musculoskeletal disorders, and poor mental health.
Current treatment options for patients with obesity include lifestyle intervention, obesity
pharmacotherapy, and bariatric surgery. The components of lifestyle intervention involve
diet, exercise, and behavior modification and should be recognized as the cornerstone of any
obesity treatment method; however, the impact of lifestyle intervention is limited in
patients with morbid obesity.
Surgical therapies with laparoscopic approach are accepted as the most effective and
persistent obesity-treatment methods, with a significant reduction in complication rates and
postoperative recovery. Gastric banding, sleeve gastrectomy, Roux-en-Y gastric bypass, and
biliopancreatic diversion are commonly performed bariatric surgical procedures worldwide.
But, the idea of scarless methods in which the video-endoscopy device is used as the primary
carrier device, expecting to achieve results at least as good as laparoscopic procedures, has
significantly developed within the last decade. Additionally, the development of effective
and safe, newer endoscopic bariatric procedures provides another adjunctive treatment for
patients with obesity who cannot handle this disease with lifestyle modification alone or who
is not a candidate for surgical procedures. Endoscopic therapies, such as intra-gastric
balloons, duodenojejunal bypass liners such as the EndoBarrier, and endoscopic suturing
platforms, have also become proposed alternatives to surgery, considering their
minimally-invasive advantages. However, given the lack of long-term data at present, the role
of such devices continues to be determined.
Newly, botulinum toxin A application into the stomach has been proposed as a treatment method
in obesity. It impacts through acetylcholine receptors located in smooth muscle cells and
suppresses stomach motility. This method aims to decrease gastric emptying time and thus to
extend the duration of feeling full. This effect of intragastric botulinum toxin A injection
(GBI) makes it easier to adhere to dietary prescriptions, which is the cornerstone of any
obesity treatment method.
Endoscopic inspections and the complicatedness in literature results, cases that have not
succeeded in losing weight after GBI might have pylorus contractility problems. Any
deterioration in pylorus activity is recognized to have the potential to influence gastric
emptying. In such a case, gastric emptying time would also be altered due to the paralysis of
pylorus muscles, which is one of the effect mechanisms of botulinum toxin A.
The pyloric orifice structure may have a crucial role in the success or failure of GBI
therapy for obesity treatment.
The present study aims to explore whether there is a correlation between weight loss after
GBI and pyloric orifice structure.
