Evaluation of the Role of Endoscopic Ultrasound Guided Gastric Botulinum Toxin Injection in the Treatment of Obesity.
1 other identifier
interventional
25
1 country
1
Brief Summary
Background: Gastric injections of Botulinum toxin A (BTA) may induce changes in gastric emptying and body weight, but results vary. BTA dose and depth of injection may affect efficacy. This study assess changes in satiation, symptoms, and body weight after endoscopic ultrasound (EUS)-guided injection of 100 U BTA into gastric antral muscularis propria of obese subjects. Methods: Open label study of twenty five healthy, obese adults (age=21-49 years, body mass index 35 = kg/m2) who received 100 U and were followed for 16 weeks. Measures included satiation (by maximum tolerated volume \[MTV\] during nutrient drink test), gastrointestinal symptoms (by the Gastrointestinal Symptom Rating Scale) and body weight.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 22, 2017
CompletedFirst Submitted
Initial submission to the registry
January 12, 2019
CompletedFirst Posted
Study publicly available on registry
April 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 22, 2019
CompletedApril 3, 2019
April 1, 2019
1.7 years
January 12, 2019
April 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
weight loss
follow up weight and satiety of the patient weekly
16 weeks
Study Arms (1)
obese patient
OTHERwe will perform endoscopic ultrasound botulinum toxin (100 IU)injection to gastric antrum of obese patient with BMI more than 30 will
Interventions
endoscopic ultrasound with boutlinum toxin injection in the antrum of the stomach to decrease satiety
Eligibility Criteria
You may qualify if:
- Sex: both
- Age: from 20 to 60 years
- Body Mass Index \> 30
You may not qualify if:
- Age: below 20 or above 60 years old.
- Patient with known gastroparesis
- Peptic ulcer disease or active upper gastrointestinal ulceration
- Prior gastric or small bowel surgery
- American Society of Anesthesiologists (ASA) class 3 or higher
- Patients with more than mild , infrequent symptoms of upper abdominal pain or nausea
- Pregnant or lactating female
- Contraindications of sedation (Uncontrolled Diabetes Mellitus, Uncontrolled Thyroid Disorders, Pregnancy, Respiratory Embarrassment, Reactional Drugs like Antidepressants and Anti-anxiety Agents).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Specialized Medical Hospital,Mansoura University
Al Mansurah, Dakhlia, 35516, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mounir H Bahgat
Mansoura University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
January 12, 2019
First Posted
April 3, 2019
Study Start
August 22, 2017
Primary Completion
April 22, 2019
Study Completion
August 22, 2019
Last Updated
April 3, 2019
Record last verified: 2019-04