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临床试验/NCT05268627
NCT05268627Unknown不适用

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

Mansoura University2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2022年1月27日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
38
试验地点
2
主要终点
weight loss

研究概览

简要总结

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.

详细描述

Introduction

Obesity is an important public health concern. Although most pharmacologic therapies have targeted the central nervous system, surgical treatments induce satiation by decreasing the size of the gastric reservoir and inducing maldigestion or malabsorption.

Surgery is effective but invasive and expensive, and some obese persons are not good surgical candidates. Promising pharmacologic and endoscopic approaches to obesity include treatments that affect gastric volume, gastric emptying, gastric compliance, and satiation.

In rats, botulinum toxin A (BTA) injected subserosally into the antrum resulted insignificant decreases in caloric intake and body weight when compared to control and injected rats. Subsequent open-label human studies and three small randomized trials have reported conflicting results, with some studies finding little or no body weight loss after gastric BTA injection and one randomized controlled trial showing statistically significant decreases in gastric emptying and body weight . These trials differed in BTA dose (100 to 300 U in Botox formulation equivalents) and location of injections (antrum alone vs. antrum, body, and cardia). Depth of injection in the gastric wall was largely unknown in these studies, as endoscopic ultrasound (EUS) was not used to guide injection into the muscularis propria or subserosal layers.

In a study by Topazian. (2008), mean body weight reduction was similar in subjects receiving 100 or 300 U BTA (5.0 vs. 4.8 kg). There was a no significant trend toward loss of more body weight in the three subjects who developed decreased gastric emptying after receiving 300 U BTA. Also EUS guidance would help to assure injection of BTA in the gastric muscularis propria and subserosal layers of the gastric wall.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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).

研究组 & 干预措施

Endoscopic Ultrasound Guided Gastric Botulinum Toxin Injections

Active Comparator

干预措施: Liraglutide (Drug)

liraglutide

Active Comparator

干预措施: Liraglutide (Drug)

结局指标

主要结局

weight loss

时间窗: 1 year

weight in kilograms

Body mass index

时间窗: 1 year

BMI weight/ height2

waist circumference

时间窗: 1 year

waist circumference in cm

hip circumference

时间窗: 1 year

hip circumference in cm

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Asmaa Gameel

principal investigator

Mansoura University

研究点 (2)

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