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Intra-gastric Fundal and Body Injection of Botulinum Toxin A for Weight Loss, a Randomized Controlled Trial

Primary Purpose

Obesity, Weight Loss

Status
Unknown status
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
Botulinum toxin type A
Weight Management Program
Sponsored by
Tan Tock Seng Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age 21 to 65yrs old
  2. BMI >32.5 (Class II obesity)

Exclusion Criteria:

  1. Pregnancy or lactation
  2. Known pre-existing neuromuscular disorders or peripheral motor neuropathic disease (e.g. amyotrophic lateral sclerosis, motor neuropathy)
  3. Patients with known liver cirrhosis or known esophageal/gastric varices
  4. Known eating disorders
  5. Known major cardiovascular or pulmonary conditions
  6. Previous gastric/bariatric surgery
  7. Pathologic changes of the esophagus/stomach/duodenum demonstrated on endoscopy (esophagitis, peptic ulcers, cancer)
  8. Known alcohol or drug abuse
  9. Known allergy to any ingredients in Botox or allergic reaction to any other botulinum toxin product

Sites / Locations

  • Tan Tock Seng HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Arm

Control Arm

Arm Description

Patients in the intervention arm will receive 300units of Botulinum Toxin A (Botox; Allergan Inc., Irvine, Ca, USA) 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. 20 separate injections of 0.5ml each will be performed in a concentric ring 1cm apart. 10 injections will be performed into the body of the stomach, and 10 injections into the fundus, from the level of the CEJ and above Patients will undergo a 12-week weight management program approximately 2 weeks after the injection of Botox.

Patients will undergo a 12-week weight management program.

Outcomes

Primary Outcome Measures

Weight loss
Examine the average weight loss
Time to weight regain following a single injection of intra-gastric Botox

Secondary Outcome Measures

Gut hormone level
Ghrelin
Gut hormone level ( Leptin)
Leptin
Satiety index
Co-morbidities
Diabetes, hypertension, hyperlipidemia

Full Information

First Posted
February 16, 2020
Last Updated
February 17, 2020
Sponsor
Tan Tock Seng Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04274608
Brief Title
Intra-gastric Fundal and Body Injection of Botulinum Toxin A for Weight Loss, a Randomized Controlled Trial
Official Title
Intra-gastric Fundal and Body Injection of Botulinum Toxin A for Weight Loss, a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tan Tock Seng Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
This is a randomized controlled trial to compare intra-gastric injection of Botulinum Toxin A (Botox; Allergan Inc. Irvine, Ca, USA) against non-surgical management for obesity (i.e. exercise/diet). Our hypothesis is that intra-gastric injection of Botox into the fundus and body of the stomach will result in greater weight loss than just exercise and diet alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Patients in the intervention arm will receive 300units of Botulinum Toxin A (Botox; Allergan Inc., Irvine, Ca, USA) 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. 20 separate injections of 0.5ml each will be performed in a concentric ring 1cm apart. 10 injections will be performed into the body of the stomach, and 10 injections into the fundus, from the level of the CEJ and above Patients will undergo a 12-week weight management program approximately 2 weeks after the injection of Botox.
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
Patients will undergo a 12-week weight management program.
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin type A
Intervention Description
Intragastric injection of Botulinum toxin type A
Intervention Type
Behavioral
Intervention Name(s)
Weight Management Program
Intervention Description
12 week weight management program
Primary Outcome Measure Information:
Title
Weight loss
Description
Examine the average weight loss
Time Frame
1 year
Title
Time to weight regain following a single injection of intra-gastric Botox
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Gut hormone level
Description
Ghrelin
Time Frame
1 year
Title
Gut hormone level ( Leptin)
Description
Leptin
Time Frame
1 year
Title
Satiety index
Time Frame
1 year
Title
Co-morbidities
Description
Diabetes, hypertension, hyperlipidemia
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 21 to 65yrs old BMI >32.5 (Class II obesity) Exclusion Criteria: 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 Previous gastric/bariatric surgery Pathologic changes of the esophagus/stomach/duodenum demonstrated on endoscopy (esophagitis, peptic ulcers, cancer) Known alcohol or drug abuse Known allergy to any ingredients in Botox or allergic reaction to any other botulinum toxin product
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danson Yeo, MBBS, MRCS, FRCS
Phone
+65 81834111
Email
danson_xw_yeo@ttsh.com.sg
Facility Information:
Facility Name
Tan Tock Seng Hospital
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danson Yeo, MBBS
Phone
+65 81834111
Email
danson_xw_yeo@ttsh.com.sg

12. IPD Sharing Statement

Learn more about this trial

Intra-gastric Fundal and Body Injection of Botulinum Toxin A for Weight Loss, a Randomized Controlled Trial

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