Endoscopic Gastric Reduction of Gastric Mucosa in Obesity

NCT ID: NCT06231251

Last Updated: 2024-01-30

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-12-01

Brief Summary

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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

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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 \[5, 6\].

Conditions

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Obesity, Morbid Endoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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control group

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

Group Type ACTIVE_COMPARATOR

upper gastrointestinal endoscopy

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

upper gastrointestinal endoscopy

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

upper gastrointestinal endoscopy

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Amr Shaaban Hanafy

professor of medicine and gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zagazig University

Zagazig, Sharqia Province, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Amr S Hanafy

Role: CONTACT

+201100061861

waseem seleem

Role: CONTACT

Facility Contacts

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Waseem Seleem, md

Role: primary

+201025264008

Amr Hanafy, md

Role: backup

+201100061861

Other Identifiers

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9352

Identifier Type: -

Identifier Source: org_study_id

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