Endoscopic Gastric Reduction of Gastric Mucosa in Obesity (ETO)

Z

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)

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

Trial contacts and locations

1

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Central trial contact

Amr S Hanafy; waseem seleem

Data sourced from clinicaltrials.gov

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