Endoscopic Gastric Reduction of Gastric Mucosa in Obesity (ETO)

Zagazig University

Status: Enrolling

Conditions: Endoscopy; Obesity, Morbid

Treatments: Other: upper gastrointestinal endoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT06231251

9352

Details and patient eligibility

About

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.

Full 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].

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 3 patient groups

control group

Active Comparator group

Description:

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

Treatment:

Other: upper gastrointestinal endoscopy

endoscopic band ligation

Active Comparator group

Description:

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

Treatment:

Other: upper gastrointestinal endoscopy

endoscopic argon plasma coagulation

Active Comparator group

Description:

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

Treatment:

Other: upper gastrointestinal endoscopy