Intragastric Injections of Botox for the Treatment of Obesity

Norwegian University of Science and Technology

Status and phase: Active, not recruiting; Phase 2

Conditions: Obesity, Morbid

Treatments: Drug: Saline solution; Drug: Botulinum Toxin Type A

Study type: Interventional

Funder types: Other

Identifiers

NCT02035397

2013/1597

2012-004381-18 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Botulinum toxin A

Experimental group

Description:

Botulinum toxin type A injection in muscles of stomach wall

Treatment:

Drug: Botulinum Toxin Type A

Saline solution

Placebo Comparator group

Description:

Placebo (saline solution) injection first 6 months, then active treatment

Treatment:

Drug: Botulinum Toxin Type A

Drug: Saline solution