Endoscopic Gastric Reduction of Gastric Mucosa in Obesity

NCT06231251 | Unknown

• 1 other identifier: 9352
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

In the stomach, the ghrelin-containing cells are more abundant in the fundus than in the pylorus originally termed X/A-like cells. These X/A-like cells account for approximately 20 % of the endocrine cell population in adult oxyntic glands. Ghrelin enhances the secretion of growth hormone, the stimulation of appetite and food intake, the modulation of gastric acid secretion \& motility and the endocrine and exocrine pancreatic secretions.

Conditions

Obesity, Morbid; Endoscopy

Outcome Measures

Primary Outcomes (1)

• Number of patients with significant weight reduction

  significant weight reduction of more than 10% of baseline body weight measured in kilograms

  6 month

Other Outcomes (1)

• Number of patients with improved insulin resistance

  6 months

Study Arms (3)

control group

ACTIVE COMPARATOR

exposed to low caloric diet (15 calories/kilogram) and exercise

Other: upper gastrointestinal endoscopy

endoscopic band ligation

ACTIVE COMPARATOR

endoscopic reduction of ghrelin rich gastric mucosa with band ligation will be applied starting from the fundus till the mid body in 3-4 rows 1-2 cm apart for luminal reduction

Other: upper gastrointestinal endoscopy

endoscopic argon plasma coagulation

ACTIVE COMPARATOR

argon plasma mediated reduction of gastric mucosa rich in ghrelin receptors by appling argon to stomach mucosa from fundus to mid body

Other: upper gastrointestinal endoscopy

Interventions

upper gastrointestinal endoscopy OTHER

reduction of ghrelin rich gastric mucosa with band ligation or argon plasma

control group; endoscopic argon plasma coagulation; endoscopic band ligation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• body mass index more than 25
• diagnosis of diabetes mellitus.
• diagnosis of cardio-metabolic syndrome.
• fatty liver disease diagnosed by abdominal ultrasound.

You may not qualify if:

• use of drugs which induce insulin resistance, diabetes and hepatic steatosis.
• excess alcohol consumption.
• chronic gastritis, active peptic ulcer.
• malignancy.
• depression and severe psychological disorders
• inability to give informed consent.
• coagulopathy (INR more than 1.5, platelets less than 50000 per cmm).
• severe cardiopulmonary comorbidity.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University

Zagazig, Sharqia Province, 44519, Egypt

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Amr S Hanafy

CONTACT

+201100061861; amrhanafy@zu.edu.eg

waseem seleem

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of medicine and gastroenterology

Model Details: endoscopic reduction of ghrelin rich gastric mucosa either with 1. band ligation (group 1; n=16) and diet control 2. argon plasma mediated reduction and diet control (group 2; n=16) 3. control group exposed to low caloric diet and exercise (group 3; n=16).

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: January 30, 2024
• Study Start: December 1, 2023
• Primary Completion: September 13, 2024
• Study Completion: December 1, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)