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Exploring Intragastric Botulinum Toxin Injections: A Prospective study on the rate of Weight Loss in Overweight and Obese Patients

Protocol summary

Study aim
Investigating the effect of intragastric botulinum toxin injection on weight loss in obese patients
Design
Clinical trial with a control group, non-randomized, single-center, single blind, with parallel groups, phase 3 on 60 patients
Settings and conduct
This study will be conducted in the gastroenterology clinic and the nutrition clinic of Taleghani Hospital. The participants will be placed in the intervention and control groups based on their choice. Patients in the intervention arm will receive 5 cc containing 500 units of botulinum toxin A (Masport) diluted in 10 ml of saline. A total of 50 units of botulinum toxin is injected at 10 sites in the stomach, targeting the antrum 5 cm above the pylorus (3 points), the body (5 points), and the fundus (2 points). All patients in the intervention and control groups are given specific calorie-restricted diets. Subsequent visits are scheduled at 4-week intervals for a total of 3 months. the study is single blinded study in which the outcome assessor and the analyst are blinded.
Participants/Inclusion and exclusion criteria
Entry criteria: body mass index between 25 and 40; absence of other comorbidities; absence of contraindications for administering botulinum toxin. Exclusion criteria: history of bariatric surgery; allergy to Mesport; pregnancy; liver cirrhosis; eating disorders; cardiovascular or pulmonary disease; diabetes
Intervention groups
The intervention group receives intragastric botulinum toxin injection under endoscopic guidance in the amount of 5 cc containing 500 units of botulinum toxin A. They also receive a low-calorie diet. The control group is subjected to a controlled low-calorie diet.
Main outcome variables
Weight, body mass index, waist circumference, hip circumference, waist-to-hip ratio, arm circumference, possible complications, patients' satisfaction with each method, lipid profile, blood glucose, HbA1C

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230408057842N2
Registration date: 2023-10-22, 1402/07/30
Registration timing: prospective

Last update: 2023-10-22, 1402/07/30
Update count: 0
Registration date
2023-10-22, 1402/07/30
Registrant information
Name
Pardis Ketabi Moghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2525
Email address
ketabimoghadam.p@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-06, 1402/08/15
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Exploring Intragastric Botulinum Toxin Injections: A Prospective study on the rate of Weight Loss in Overweight and Obese Patients
Public title
The effect of botulinum in obese patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Body mass index (BMI) between 25-39.9 kg/m^2 Willingness to participate in the intervention Absence of any other comorbidity Absence of any contraindications for botulinum toxin administration
Exclusion criteria:
Participants with a history of previous bariatric surgery BMI≥40 kg/m^2 Known allergy to any ingredients in Masport or allergic reaction Pregnancy or lactation Known pre-existing neuromuscular disorders or peripheral motor neuropathic disease (e.g. amyotrophic lateral sclerosis, motor neuropathy) Patients with known liver cirrhosis or known esophageal/gastric varices Known eating disorders Known major cardiovascular or pulmonary conditions Diabetes Pathologic changes of the esophagus/stomach/duodenum demonstrated on endoscopy (esophagitis, peptic ulcers, cancer) Known alcohol or drug abuse
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the person evaluating the outcomes in both intervention and control groups does not know which group each patient is assigned to. Also, the names of the patients along with their other information are provided to the analyst in coded form to avoid any bias.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
research ethic committee of research institute for gastroenterology and liver disease
Street address
Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-09-04, 1402/06/13
Ethics committee reference number
IR.SBMU.RIGLD.REC.1402.002

Health conditions studied

1

Description of health condition studied
Overweight and obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity

Primary outcomes

1

Description
weight
Timepoint
before the intervention and three months later
Method of measurement
scales

2

Description
body mass index
Timepoint
before the intervention and three months later
Method of measurement
Height to weight ratio formula

3

Description
waist circumference
Timepoint
before the intervention and three months later
Method of measurement
meter

4

Description
hip circumference
Timepoint
before the intervention and three months later
Method of measurement
meter

5

Description
waist-to-hip ratio
Timepoint
before the intervention and three months later
Method of measurement
waist-to-hip ratio formula

6

Description
arm circumference
Timepoint
before the intervention and three months later
Method of measurement
meter

7

Description
lipid profile
Timepoint
before the intervention and three months later
Method of measurement
laboratory kits

8

Description
blood glucose
Timepoint
before the intervention and three months later
Method of measurement
laboratory kits

9

Description
HbA1c
Timepoint
before the intervention and three months later
Method of measurement
laboratory kits

Secondary outcomes

1

Description
side effects
Timepoint
before the intervention and three months later
Method of measurement
Patient examination and history

2

Description
patients' satisfaction with each method
Timepoint
before the intervention and three months later
Method of measurement
Questionnaire of satisfaction with weight loss program

Intervention groups

1

Description
Intervention group: The intervention group receives intragastric botulinum toxin injections under endoscopic guidance. Patients in the intervention arm will receive 5cc containing 500units of Botulinum Toxin A (Masport; MasoonDarou Pharmaceutical Company; Iran) diluted to 10mls of saline. Endoscopy will be performed using a single-lumen gastroscope. Injection of the solution will be done using a 23Gauge Interject needle catheter. 10 separate injections of 1.5ml each will be performed in a concentric ring 5cm apart. A total of 50 units of botulinum toxin are injected at 10 sites in the stomach, targeting antrum 5cm above the pylorus (3 points), body (5 points), and fundus (2 points). Also, they receive a limited diet with specific calories.
Category
Treatment - Surgery

2

Description
Control group: Participants receive standardized nutritional counseling by a registered dietitian. They are given specific calorie-restricted diets that aim to lose 0.5-1 kg of weight per week.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
gastroenterology and liver disease clinic, Taleghani hospital
Full name of responsible person
Mohammad Javad Ehsani Ardakani
Street address
Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۱۱۵۱
Phone
+98 21 2303 1505
Email
info@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Zahedi
Position
Gastroenterologist assistant
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 2525
Email
a.zahedi2013@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Javad Ehsani Ardakani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 2525
Email
mjehsani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Pardis Ketabi Moghadam
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 2525
Email
ketabimoghadam.p@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Only the information related to the study protocol, statistical analysis plan and clinical study report will be made available to the requestors (and not publicly) to other researchers for guidance for further studies.
When the data will become available and for how long
After the publication of the article
To whom data/document is available
Researchers, students and professors in the field of digestion and nutrition
Under which criteria data/document could be used
For use in further research and if the source is cited
From where data/document is obtainable
Corresponding author Dr. Pardis Ketabi Moghadam ketabimoghadam.p@sbmu.ac.ir
What processes are involved for a request to access data/document
Send a request via email to the responsible author and mention the reason for the request and how to use the tens
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