Intragastric Injections of Botox for the Treatment of Obesity
This trial is active, not recruiting.
|Treatments||botulinum toxin type a, saline solution|
|Sponsor||Norwegian University of Science and Technology|
|Collaborator||St. Olavs Hospital|
|Start date||February 2014|
|End date||December 2022|
|Trial size||20 participants|
|Trial identifier||NCT02035397, 2012-004381-18, 2013/1597|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, outcomes assessor)|
time frame: Change from baseline to 6 months; 1 year; 5 years
Male or female participants from 18 years up to 60 years old.
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
|Official title||Treatment of Morbid Obesity by Intragastric Injections of Botulinum Toxin A. A Randomized, Double-blind, Placebo Controlled, Phase II-trial|
|Principal investigator||Bård Kulseng, MD, PhD|
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