Effectiveness of intragastric injection of botulinum toxin obese patients

Phase 1

Conditions: Morbid obesity
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2015-004391-29-ES

Lead Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br> - To compare other anthropometric values between treatment group and control group.<br>- To check level differences between postprandial satiety treatment group and control group.<br>- To compare caloric intake between treatment group and control group.<br>- To compare levels of mediators of appetite and satiety between treatment group and control group.<br>- To identify possible variations in quality of life between treatment group and control group.<br>;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 Outcome Measures

Name	Time	Method
Secondary end point(s): - To identify the presence of gastrointestinal symptoms de novo with the performance of the technique.<br> - To compare other anthropometric values between treatment group and control group.<br>- To check level differences between postprandial satiety treatment group and control group.<br>- To compare caloric intake between treatment group and control group.<br>- To compare levels of mediators of appetite and satiety between treatment group and control group.<br>- To identify possible variations in quality of life between treatment group and control group.<br>;Timepoint(s) of evaluation of this end point: After 2, 8 and 24 weeks