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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04274608
• Other study ID #: TanTockSengH
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 1, 2020
• Est. completion date: July 2022

Study information

• Verified date: February 2020
• Source: Tan Tock Seng Hospital
• Contact: Danson Yeo, MBBS, MRCS, FRCS
• Phone: +65 81834111
• Email: danson_xw_yeo[@]ttsh.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: July 2022
• Est. primary completion date: July 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Weight Loss

Intervention

Drug:
• Botulinum toxin type A
Intragastric injection of Botulinum toxin type A

Behavioral:
• Weight Management Program
12 week weight management program

Locations

Country	Name	City	State
Singapore	Tan Tock Seng Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Tan Tock Seng Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	Examine the average weight loss	1 year
Primary	Time to weight regain following a single injection of intra-gastric Botox		1 year
Secondary	Gut hormone level	Ghrelin	1 year
Secondary	Gut hormone level ( Leptin)	Leptin	1 year
Secondary	Satiety index		1 year
Secondary	Co-morbidities	Diabetes, hypertension, hyperlipidemia	1 year