Endoscopic Gastric Reduction of Gastric Mucosa in Obesity

Not Applicable

Recruiting

• Conditions: Obesity, Morbid; Endoscopy
• Interventions: Other: upper gastrointestinal endoscopy

• Registration Number: NCT06231251
• Lead Sponsor: Zagazig University

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.

Detailed Description

Ghrelin is 28 amino acid peptide hormone, approximately 70 % of circulating ghrelin is secreted by the stomach, with most of the remainder originating in duodenum, jejunum, and ileum. Lower amount of secretion outside the gut, including hypothalamus (arcuate nucleus and paraventricular nucleus), pituitary, lung, adrenal cortex, kidney, bone, testis, placenta and pancreatic islet cells 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. Synthetic ghrelin imitative was shown to increase fat deposition and appetite through an action at the level of the hypothalamus arcuate nucleus mainly the orexigenic neuropeptide Y (NPY) neurons.

Alterations of ghrelin play an important role in appetite fluctuation following meals. The secretion of ghrelin by the stomach depends largely on the nutritional state. Ghrelin levels show pre-prandial increases and postprandial decreases.

Low systemic ghrelin levels have been reported in untreated hyperthyroidism, in male hypogonadism, in the polycystic ovary syndrome, or after total gastrectomy \[5, 6\].

Study Timeline

• Study First Submitted: 2022-06-30
• Study Start: 2023-12-01
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-19
• Last Update Submitted: 2024-01-19
• Study First Posted: 2024-01-30
• Last Update Posted: 2024-01-30
• Primary Completion: 2024-09-13
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
endoscopic band ligation	upper gastrointestinal endoscopy	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
endoscopic argon plasma coagulation	upper gastrointestinal endoscopy	argon plasma mediated reduction of gastric mucosa rich in ghrelin receptors by appling argon to stomach mucosa from fundus to mid body
control group	upper gastrointestinal endoscopy	exposed to low caloric diet (15 calories/kilogram) and exercise

Primary Outcome Measures

Name	Time	Method
Number of patients with significant weight reduction	6 month	significant weight reduction of more than 10% of baseline body weight measured in kilograms

Trial Locations

Locations (1)

Zagazig University; 🇪🇬 Zagazig, Sharkia, Egypt