Endoscopic Ultrasound Guided Gastric Botulinum Toxin Injections Versus Glucagon Like Peptide 1 Receptor Agonist in Weight Loss

• Status: Recruiting
• Trial end date: 2023-01-27
• Target enrollment: 0
• Participant gender: All

Summary

Background: Obesity is an important public health concern. Surgery is effective but invasive and expensive, and some obese persons are not good surgical candidates.

Aim:

Compare safety, feasibility and efficacy of endoscopic ultrasound guided boutlinum toxin injection and GLP-1 agonists in treatment of obesity.

Methods Full written informed consent will be obtained from all patients.Patient demographics.Detailed medical history.Complete clinical examination.The two methods of intervention will be combined with prescription of several life style modifications as a 2000 kcal diet in men, or 1800kcal in women and moderate daily aerobic exercise (at least 30 minutes, 5 times a week) during 4 months and body weight will be assessed during a 16-week follow-up period.BTA group:Esophagogastroduodenoscopy (EGD) will be done to all subjects under conscious sedation. If no ulceration or retained food, EUS and BTA injection will be performed under the same sedation. EUS examinations will be performed. BTA injections will be made via a 25-gauge EUS needle. A ring of five injections will be made into the gastric antral muscularis propria, 2 to 3 cm proximal to the pylorus. The subjects will receive 20 U at each injection. Subjects will be assessed for complications after recovery from conscious sedation and, again, by telephone the next day.During a 16-week follow-up period after BTA injections, subjects will be weighed weekly.GLP1 group:GLP-1 receptor agonist (Liraglutide subcutaneous once daily).We will start by 0.6 mg daily and we will raise the dose up to 3 mg gradually if patient tolerated.During a 16 week follow up period, subjects will be weighed weekly.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mansoura University
• Treatments: Liraglutide

Criteria

Inclusion Criteria:

Sex: both Age: from 20 to 60 years Body Mass Index > 30

Exclusion Criteria:

Age: below 20 or above 60 years old. Patient with known gastroparesis Peptic ulcer disease or active upper gastrointestinal ulceration Prior gastric or small bowel surgery American Society of Anesthesiologists (ASA) class 3 or higher Patients with more than mild , infrequent symptoms of upper abdominal pain or nausea Pregnant or lactating female Contraindications of sedation (Uncontrolled Diabetes Mellitus, Uncontrolled Thyroid Disorders, Pregnancy, Respiratory Embarrassment, Reactional Drugs like Antidepressants and Anti-anxiety Agents).