Intragastric Injections of Botox for the Treatment of Obesity

Phase 2

Active, not recruiting

• Conditions: Obesity, Morbid
• Interventions: Drug: Botulinum Toxin Type A; Drug: Saline solution

• Registration Number: NCT02035397
• Lead Sponsor: Norwegian University of Science and Technology

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-01-12
• Study First Submitted QC: 2014-01-12
• Study First Posted: 2014-01-14
• Study Start: 2014-02
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-07
• Last Update Posted: 2022-10-10
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• BMI > 35

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline solution	Botulinum Toxin Type A	Placebo (saline solution) injection first 6 months, then active treatment
Botulinum toxin A	Botulinum Toxin Type A	Botulinum toxin type A injection in muscles of stomach wall
Saline solution	Saline solution	Placebo (saline solution) injection first 6 months, then active treatment

Primary Outcome Measures

Name	Time	Method
Body weight	Change from baseline to 6 months; 1 year; 5 years

Trial Locations

Locations (1)

St. Olavs Hospital, Trondheim University Hospital; 🇳🇴 Trondheim, Norway