NCT05268627

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

Status unknown NA Last updated 7 March 2022

What this trial tests

NA trial testing Liraglutide in Obesity in 38 participants. Status unknown.

Timeline

27 January 2022

Primary endpoint
27 January 2023

27 January 2023

Quick facts

Lead sponsor	Mansoura University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	38
Start date	27 January 2022
Primary completion	27 January 2023
Estimated completion	27 January 2023
Sites	2 locations across Egypt

Drugs / interventions tested

• Liraglutide (liraglutide) — full drug profile →

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

Mansoura University

Who can join

Adults 20 to 60, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Endoscopic Ultrasound Guided Gastric Botulinum Toxin Injections versus Glucagon like peptide 1 Receptor Agonist in weight loss. A Prospective randomized study
   Gameel A, Altonbary A, Kyrillos F, Elbialy A. · · 2023 · cited 1× · DOI 10.21203/rs.3.rs-3196471/v1