Obesity, Morbid
Conditions
Keywords
botulinum toxin, Endoscopy, Satiation, Diet, Weight Loss
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.
Interventions
DRUGBotulinum Toxin Type A
DRUGSaline solution
Sponsors
St. Olavs Hospital
Norwegian University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body weight | Change from baseline to 6 months; 1 year; 5 years |
Countries
Norway
Outcome results
None listed