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OpenTrials
Completed

NCT Number: NCT04948177

Outcome of Gastric Fundus and Pylorus Botulinum Toxin A Injection

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Okan University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-Class I obese patients and class II obese patients with no comorbidities

Exclusion criteria

  • Patients with type 3-4 hiatal hernia according to flap-valve grading system
  • Los Angeles type B-C esophagitis
  • Type I-II ulcer
  • Malignant or suspected malignant lesion in stomach
  • Age <18 or >70
  • Patients use drugs affecting gastric contractility and pyrokinesis
  • Patients have endocrine system problems (hypothyroidism and Cushing syndrome), active psychiatric disorder were not accepted as a candidate for GBI therapy.

Treatment and study plan

Primary outcomes

  1. Body Mass Index Change

    Time frame: 6 months

    The body mass index change in six months period is observed

Secondary outcomes

  1. Weight change

    Time frame: 6 months

    The weight change in six months period is observed

Sponsors and collaborators

Lead sponsor

Okan University

Other

Registry information

Official study title

Outcome of Gastric Fundus and Pylorus Botulinum Toxin A Injection in Obese Patients Class I-II With Normal Pyloric Orifice Structure: A Retrospective Analysis

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jul 1, 2021
Registry last updated
Jul 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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