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Evaluation of the Role of Endoscopic Ultrasound Guided Gastric Botulinum Toxin Injection in the Treatment of Obesity.

NCT03901040 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-04-03

No results posted yet for this study

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.

Conditions

  • Endoscopy

Interventions

DEVICE

endoscopic ultrasound

endoscopic ultrasound with boutlinum toxin injection in the antrum of the stomach to decrease satiety

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Mounir H Bahgat · Mansoura University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-22
Primary Completion
2019-04-22
Completion
2019-08-22

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03901040 on ClinicalTrials.gov