Endoscopic Gastric Reduction of Gastric Mucosa in Obesity
NCT ID: NCT06231251
Last Updated: 2024-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
48 participants
INTERVENTIONAL
2023-12-01
2024-12-01
Brief Summary
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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.
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Detailed Description
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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 \[5, 6\].
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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).
TREATMENT
NONE
Study Groups
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control group
exposed to low caloric diet (15 calories/kilogram) and exercise
upper gastrointestinal endoscopy
reduction of ghrelin rich gastric mucosa with band ligation or argon plasma
endoscopic band ligation
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
upper gastrointestinal endoscopy
reduction of ghrelin rich gastric mucosa with band ligation or argon plasma
endoscopic argon plasma coagulation
argon plasma mediated reduction of gastric mucosa rich in ghrelin receptors by appling argon to stomach mucosa from fundus to mid body
upper gastrointestinal endoscopy
reduction of ghrelin rich gastric mucosa with band ligation or argon plasma
Interventions
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upper gastrointestinal endoscopy
reduction of ghrelin rich gastric mucosa with band ligation or argon plasma
Eligibility Criteria
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Inclusion Criteria
* diagnosis of diabetes mellitus.
* diagnosis of cardio-metabolic syndrome.
* fatty liver disease diagnosed by abdominal ultrasound.
Exclusion Criteria
* 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.
18 Years
50 Years
ALL
Yes
Sponsors
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Zagazig University
OTHER_GOV
Responsible Party
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Amr Shaaban Hanafy
professor of medicine and gastroenterology
Locations
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Zagazig University
Zagazig, Sharqia Province, Egypt
Countries
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Central Contacts
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waseem seleem
Role: CONTACT
Facility Contacts
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Other Identifiers
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9352
Identifier Type: -
Identifier Source: org_study_id
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