Obesity, MorbidETONCT06231251
Endoscopic Gastric Reduction of Gastric Mucosa in Obesity
A study testing upper gastrointestinal endoscopy in people with Obesity, Morbid and Endoscopy, run by Zagazig University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Morbid, Endoscopy
- What is being tested?
- upper gastrointestinal endoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- body mass index more than 25
- diagnosis of diabetes mellitus.
- diagnosis of cardio-metabolic syndrome.
- fatty liver disease diagnosed by abdominal ultrasound.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
waseem seleem contact
Egypt1 site, 1 recruiting
- Recruiting
Zagazig University
Zagazig, Sharqia Province, 44519
Waseem Seleem, md, +201025264008, waseemmohamed1975@gmail.com
Amr Hanafy, md, +201100061861, dr_amr_hanafy@yahoo.com
About this study
Official title: 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.
Read the 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].
- Conditions
- Obesity, Morbid, Endoscopy
- Being tested
- upper gastrointestinal endoscopy
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
upper gastrointestinal endoscopyOther
reduction of ghrelin rich gastric mucosa with band ligation or argon plasma
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | exposed to low caloric diet (15 calories/kilogram) and exercise Receives: Other: upper gastrointestinal endoscopy |
| endoscopic band ligation | Active comparator | 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 Receives: Other: upper gastrointestinal endoscopy |
| endoscopic argon plasma coagulation | Active comparator | argon plasma mediated reduction of gastric mucosa rich in ghrelin receptors by appling argon to stomach mucosa from fundus to mid body Receives: Other: upper gastrointestinal endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with significant weight reduction
significant weight reduction of more than 10% of baseline body weight measured in kilograms
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Dec 2023
- Primary completion13 Sep 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Amr Shaaban Hanafy, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231251
- Sponsor's protocol ID
- 9352
- Acronym
- ETO
- Status last verified
- Jan 2024
- First submitted
- 30 Jun 2022
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Endoscopic Gastric Reduction of Ghrelin Receptors Rich Gastric Mucosa on Obesity and Metabolic Syndrome: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06231251
- Acronym / sponsor ID
- ETO / 9352
- Conditions
- Obesity, Morbid, Endoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 13 Sep 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: upper gastrointestinal endoscopyexposed to low caloric diet (15 calories/kilogram) and exercise |
| endoscopic band ligation | Active comparator | Other: upper gastrointestinal endoscopyendoscopic 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 |
| endoscopic argon plasma coagulation | Active comparator | Other: upper gastrointestinal endoscopyargon plasma mediated reduction of gastric mucosa rich in ghrelin receptors by appling argon to stomach mucosa from fundus to mid body |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- body mass index more than 25
- diagnosis of diabetes mellitus.
- diagnosis of cardio-metabolic syndrome.
- fatty liver disease diagnosed by abdominal ultrasound.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| upper gastrointestinal endoscopyreduction of ghrelin rich gastric mucosa with band ligation or argon plasma | Other | control group, endoscopic argon plasma coagulation, endoscopic band ligation |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
waseem seleem contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing upper gastrointestinal endoscopy in people with Obesity, Morbid and Endoscopy, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr S Hanafy (+201100061861, amrhanafy@zu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with significant weight reduction (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.