Intragastric Injections of Botox for the Treatment of Obesity

Obesity, Morbid Clinical Trial

Official title:

Treatment of Morbid Obesity by Intragastric Injections of Botulinum Toxin A. A Randomized, Double-blind, Placebo Controlled, Phase II-trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02035397
• Other study ID #: 2013/1597
• Secondary ID: 2012-004381-18
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 2014
• Est. completion date: December 2022

Study information

• Verified date: October 2022
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

One possible angle for treating obesity could be slowing down the gastric emptying time. By prolonging the gastric emptying time, the person would ideally experience increased sensation of satiety, and in the long run reduce food intake. If such a treatment provides a clinically significant weight loss, this could be an alternative for surgical procedures, avoiding the risk for perioperative complications as well as complications in the long run.

There are now several pilot studies documenting that intragastric treatment with botulinum toxin A (BTA) can be effective, although the treatment perspective is short and do not include repeated injections. However, they demonstrate that BTA-injections are safe for the patient. The treatment is administered by endoscopy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• BMI > 35

Exclusion Criteria:

• Known hypersensitivity to medication

• Neuro muscular disease

• Dysphagia

• Tendency for aspiration

• Ulcus

• Use of aminoglycoside antibiotics and/or spectinomycin lately

• Previous side effects of botox injections

• Previous bariatric surgery

• Previous cancer in GI-tract

• Other obesity treatment last 12 months

• Severe eating disorder

• Hypothyroidism

• Pregnancy/brest feeding

• Reduced competence to consent

Related Conditions & MeSH terms

• Obesity
• Obesity, Morbid

Intervention

Drug:
• Botulinum Toxin Type A

• Saline solution

Locations

Country	Name	City	State
Norway	St. Olavs Hospital, Trondheim University Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight		Change from baseline to 6 months; 1 year; 5 years