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

Primary Purpose

Endoscopy

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
endoscopic ultrasound
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endoscopy

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Specialized Medical Hospital,Mansoura UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

obese patient

Arm Description

we will perform endoscopic ultrasound botulinum toxin (100 IU)injection to gastric antrum of obese patient with BMI more than 30 will

Outcomes

Primary Outcome Measures

weight loss
follow up weight and satiety of the patient weekly

Secondary Outcome Measures

Full Information

First Posted
January 12, 2019
Last Updated
April 1, 2019
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT03901040
Brief Title
Evaluation of the Role of Endoscopic Ultrasound Guided Gastric Botulinum Toxin Injection in the Treatment of Obesity.
Official Title
Evaluation of the Role of Endoscopic Ultrasound Guided Botulinum Toxin Injection in the Treatment of Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 22, 2017 (Actual)
Primary Completion Date
April 22, 2019 (Anticipated)
Study Completion Date
August 22, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
obese patient
Arm Type
Other
Arm Description
we will perform endoscopic ultrasound botulinum toxin (100 IU)injection to gastric antrum of obese patient with BMI more than 30 will
Intervention Type
Device
Intervention Name(s)
endoscopic ultrasound
Intervention Description
endoscopic ultrasound with boutlinum toxin injection in the antrum of the stomach to decrease satiety
Primary Outcome Measure Information:
Title
weight loss
Description
follow up weight and satiety of the patient weekly
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asmaa G Ahmed, Master
Phone
01025835429
Ext
20
Email
asmaagameel165@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Y Altonbary, MD
Phone
01005100091
Ext
20
Email
a.altonbary@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mounir H Bahgat
Organizational Affiliation
Mansoura University
Official's Role
Study Chair
Facility Information:
Facility Name
Specialized Medical Hospital,Mansoura University
City
Mansourah
State/Province
Dakhlia
ZIP/Postal Code
35516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asmaa G Ahmed
Phone
01025835429
Ext
20
Email
asmaagameel165@gmail.com
First Name & Middle Initial & Last Name & Degree
Ahmed Y Altonbary
Phone
01005100091
Ext
20
Email
a.altonbary@gmail.com
First Name & Middle Initial & Last Name & Degree
Asmaa G Ahmed, Master
First Name & Middle Initial & Last Name & Degree
Mounir H Bahagt, MD
First Name & Middle Initial & Last Name & Degree
Seham A Seif, MD
First Name & Middle Initial & Last Name & Degree
Maha A Ragab, MD
First Name & Middle Initial & Last Name & Degree
Ahmed Y Altonbary, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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