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

April 1, 2019 updated by: Asmaa Gameel, Mansoura University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Subjects:

Twenty five overweight, healthy subjects were recruited. Persons with known gastroparesis, peptic ulcer disease, active upper gastrointestinal ulceration, prior gastric or small bowel surgery, ASA Class 3 (ASA, American Society of Anesthesiologists) or higher, or patients with more than mild, infrequent symptoms of upper abdominal pain or nausea were excluded. Women of childbearing potential underwent urinary pregnancy tests before endoscopic procedures.

Measures:

Satiation was assessed with the nutrient drink test, following the method of Tack et al. Subjects ingested 120 ml of a nutrient drink (Ensure®) per 4 min. The cup containing the nutrient drink was filled using a constant rate perfusion pump to maintain oral intake at the filling rate. Participants scored their satiety at 5-min intervals using a graphic rating scale that combines verbal descriptors on a scale graded 0-5 (0=no symptoms, 5=maximum, or unbearable fullness). Participants stopped meal intake when a score of 5 was reached, and the maximum tolerated volume (MTV) of nutrient drink was recorded. Normal values for MTV in adults in our laboratory are ≥850 cc. Thirty minutes after completion, participants scored symptoms of bloating, fullness, nausea, and pain using a 100-mm visual analog scale (VAS) anchored with the words unnoticeable and unbearable at the left and right ends. The aggregate symptom score was defined as the sum of the VAS scores for each symptom (i.e., maximum 400).

Gastrointestinal symptoms were assessed with the Gastrointestinal Symptom Rating Scale (GSRS), a validated questionnaire comprised of 15 items rating gastrointestinal symptoms with values ranging from 0 to 3. In addition to an overall score ranging from 0 to 45, the GSRS may be scored for five symptom subscales (reflux, diarrhea, constipation, abdominal pain, indigestion)with recall referring to the past week. It is responsive to change.

Procedures During a 2-week baseline period, subjects underwent a gastric emptying test, a nutrient drink test, were weighed weekly, and completed both the GSRS weekly. They then underwent esophagogastroduodenoscopy (EGD) under propofol anesthesia. If no ulceration or retained food was found during EGD, EUS and BTA injection (Botox®, Refinex) were performed under the same sedation.

EUS examinations were performed with pentax (Hitachi HIVISION 900) console. ??). BTA injections were made via a 25-gauge EUS needle. Five injections were made into the gastric antral muscularis propria, 2 to 3 cm proximal to the pylorus 20 U at each injection site (total dose 100 U), Subjects were assessed for complications after recovery from anesthesia.

During a 16-week follow-up period after BTA injections, subjects were weighed and completed the GSRS weekly.

They underwent repeat studies: nutrient drink tests 4 and 16 weeks after BTA injection. No behavioral or dietary interventions were offered to study subjects.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Dakhlia
      • Mansourah, Dakhlia, Egypt, 35516
        • Recruiting
        • Specialized Medical Hospital,Mansoura University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Asmaa G Ahmed, Master
        • Sub-Investigator:
          • Mounir H Bahagt, MD
        • Sub-Investigator:
          • Seham A Seif, MD
        • Sub-Investigator:
          • Maha A Ragab, MD
        • Sub-Investigator:
          • Ahmed Y Altonbary, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Sex: both
  • Age: from 20 to 60 years
  • Body Mass Index > 30

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: obese patient
we will perform endoscopic ultrasound botulinum toxin (100 IU)injection to gastric antrum of obese patient with BMI more than 30 will
Device: endoscopic ultrasound
endoscopic ultrasound with boutlinum toxin injection in the antrum of the stomach to decrease satiety

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight loss
Time Frame: 16 weeks
follow up weight and satiety of the patient weekly
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Study Chair: Mounir H Bahgat, Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2017

Primary Completion (Anticipated)

April 22, 2019

Study Completion (Anticipated)

August 22, 2019

Study Registration Dates

First Submitted

January 12, 2019

First Submitted That Met QC Criteria

April 1, 2019

First Posted (Actual)

April 3, 2019

Study Record Updates

Last Update Posted (Actual)

April 3, 2019

Last Update Submitted That Met QC Criteria

April 1, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD/17.08.92

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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