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

NCT05268627 | Unknown

• 1 other identifier: R.21.10.1495
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

Brief 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

Obesity

Outcome Measures

Primary Outcomes (4)

• weight loss

  weight in kilograms

  1 year

• Body mass index

  BMI weight/ height2

  1 year

• waist circumference

  waist circumference in cm

  1 year

• hip circumference

  hip circumference in cm

  1 year

Study Arms (2)

Endoscopic Ultrasound Guided Gastric Botulinum Toxin Injections

ACTIVE COMPARATOR

Drug: Liraglutide

liraglutide

ACTIVE COMPARATOR

Drug: Liraglutide

Interventions

Liraglutide DRUG

endoscopy

Also known as: Endoscopic ultrasound

Endoscopic Ultrasound Guided Gastric Botulinum Toxin Injections; liraglutide

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (2)

Specialized Medical Hospital,Mansoura University

Al Mansurah, Dakhlia, 35516, Egypt

RECRUITING

MansouraU

Al Mansurah, Egypt

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Liraglutide; Endoscopic Ultrasound-Guided Fine Needle Aspiration

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: March 7, 2022
• Study Start: January 27, 2022
• Primary Completion: January 27, 2023
• Study Completion: January 27, 2023
• Last Updated: March 7, 2022

Record last verified: 2022-02

Locations

EG (2)