Endoscopic Gastric Reduction of Gastric Mucosa in Obesity (ETO)
Impact of Endoscopic Gastric Reduction of Ghrelin Receptors Rich Gastric Mucosa on Obesity and Metabolic Syndrome: a Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Amr S Hanafy
- Phone Number: +201100061861
- Email: amrhanafy@zu.edu.eg
Study Contact Backup
- Name: waseem seleem
Study Locations
-
-
Sharkia
-
Zagazig, Sharkia, Egypt, 44519
- Recruiting
- Zagazig University
-
Contact:
- Amr Hanafy, md
- Phone Number: +201100061861
- Email: dr_amr_hanafy@yahoo.com
-
Contact:
- Waseem Seleem, md
- Phone Number: +201025264008
- Email: waseemmohamed1975@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control group
exposed to low caloric diet (15 calories/kilogram) and exercise
|
reduction of ghrelin rich gastric mucosa with band ligation or argon plasma
|
|
Active Comparator: 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
|
reduction of ghrelin rich gastric mucosa with band ligation or argon plasma
|
|
Active Comparator: 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
|
reduction of ghrelin rich gastric mucosa with band ligation or argon plasma
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patients with significant weight reduction
Time Frame: 6 month
|
significant weight reduction of more than 10% of baseline body weight measured in kilograms
|
6 month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patients with improved insulin resistance
Time Frame: 6 months
|
significant decrease in insulin resistance through assessing Homeostatic Model Assessment for Insulin Resistance, calculated by using the following formula: fasting glucose (mg/dL) X fasting insulin (µU/mL) / 405
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9352
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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