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

NCT05268627 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2022-03-07

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Liraglutide

endoscopy

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-27
Primary Completion
2023-01-27
Completion
2023-01-27

Countries

  • Egypt

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05268627 on ClinicalTrials.gov