IRCT20230408057842N2
Recruiting
Phase 3
Exploring Intragastric Botulinum Toxin Injections: A Prospective study on the rate of Weight Loss in Overweight and Obese Patients
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Shahid Beheshti University of Medical Sciences
- Enrollment
- 60
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Body mass index (BMI) between 25\-39\.9 kg/m^2
- •Willingness to participate in the intervention
- •Absence of any other comorbidity
- •Absence of any contraindications for botulinum toxin administration
Exclusion Criteria
- •Participants with a history of previous bariatric surgery
- •BMI\=40 kg/m^2
- •Known allergy to any ingredients in Masport or allergic reaction
- •Pregnancy or lactation
- •Known pre\-existing neuromuscular disorders or peripheral motor neuropathic disease (e.g. amyotrophic lateral sclerosis, motor neuropathy)
- •Patients with known liver cirrhosis or known esophageal/gastric varices
- •Known eating disorders
- •Known major cardiovascular or pulmonary conditions
- •Pathologic changes of the esophagus/stomach/duodenum demonstrated on endoscopy (esophagitis, peptic ulcers, cancer)
- •Known alcohol or drug abuse
Outcomes
Primary Outcomes
Not specified
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