NCT04274608

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for phase_2 obesity

Timeline
Completed

Started Jan 2020

Typical duration for phase_2 obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

1.5 years

First QC Date

February 16, 2020

Last Update Submit

February 17, 2020

Conditions

ObesityWeight Loss

Outcome Measures

Primary Outcomes (2)

  • Weight loss

    Examine the average weight loss

    1 year

  • Time to weight regain following a single injection of intra-gastric Botox

    1 year

Secondary Outcomes (4)

  • Gut hormone level

    1 year

  • Gut hormone level ( Leptin)

    1 year

  • Satiety index

    1 year

  • Co-morbidities

    1 year

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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.

Drug: Botulinum toxin type ABehavioral: Weight Management Program

Control Arm

ACTIVE COMPARATOR

Patients will undergo a 12-week weight management program.

Behavioral: Weight Management Program

Interventions

Botulinum toxin type ADRUG

Intragastric injection of Botulinum toxin type A

Intervention Arm
Weight Management ProgramBEHAVIORAL

12 week weight management program

Control ArmIntervention Arm

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 21 to 65yrs old
  • BMI \>32.5 (Class II obesity)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tan Tock Seng Hospital

Singapore, 308433, Singapore

RECRUITING

MeSH Terms

Conditions

ObesityWeight Loss

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Central Study Contacts

Danson Yeo, MBBS, MRCS, FRCS

CONTACT

+65 81834111danson_xw_yeo@ttsh.com.sg

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Consultant

Study Record Dates

First Submitted

February 16, 2020

First Posted

February 18, 2020

Study Start

January 1, 2020

Primary Completion

July 1, 2021

Study Completion

July 1, 2022

Last Updated

February 18, 2020

Record last verified: 2020-02

Locations

SG(1)