Morbid obesity
Conditions
Interventions
Trade Name: BOTOX
Product Name: botulinum toxin
Product Code: 93384-43-1
Pharmaceutical Form: Powder for concentrate for solution for injection/infusion
INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXI
Sponsors
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female 2. Age 18-65 years 3. BMI> 40 or BMI> 35 with comorbidities 4. Waiting list for bariatric surgery between 6 and 12 months before the intervention. 5. Willingness to attend scheduled visits Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. Obesity of endocrine origin. 2. Recent anti-obesity 2 treatment (<3 months). 3. myopathy, known neuromuscular or neurological disease 4. Severe Psychopathology contraindicating procedure 5. active gastrointestinal disease (esophagitis, peptic ulcer, cancer, etc., already diagnosed). 6. History of gastric surgery. 7. previous botulism. 8. dysfunction of gastrointestinal motility because of opioids, anticholinergics or other drugs. 9. known intolerance upper endoscopy. 10. Pregnant or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of intragastric toxin on weight loss in obese patients before bariatric surgery.;Secondary Objective: - To identify the presence of gastrointestinal symptoms de novo with the performance of the technique. - To compare other anthropometric values between treatment group and control group. - To check level differences between postprandial satiety treatment group and control group. - To compare caloric intake between treatment group and control group. - To compare levels of mediators of appetite and satiety between treatment group and control group. - To identify possible variations in quality of life between treatment group and control group. ;Primary end point(s): To determine the effect of intragastric toxin on weight loss in obese patients before bariatric surgery.;Timepoint(s) of evaluation of this end point: After 2, 4, 8, 16 and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - To identify the presence of gastrointestinal symptoms de novo with the performance of the technique. - To compare other anthropometric values between treatment group and control group. - To check level differences between postprandial satiety treatment group and control group. - To compare caloric intake between treatment group and control group. - To compare levels of mediators of appetite and satiety between treatment group and control group. - To identify possible variations in quality of life between treatment group and control group. ;Timepoint(s) of evaluation of this end point: After 2, 8 and 24 weeks | — |
Countries
Spain
Contacts
Public ContactGloria Luque-Fernandez
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS)
Outcome results
None listed