Nctid:
NCT06231251
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D009765", "term"=>"Obesity"}, {"id"=>"D009767", "term"=>"Obesity, Morbid"}], "ancestors"=>[{"id"=>"D050177", "term"=>"Overweight"}, {"id"=>"D044343", "term"=>"Overnutrition"}, {"id"=>"D009748", "term"=>"Nutrition Disorders"}, {"id"=>"D001835", "term"=>"Body Weight"}], "browseLeaves"=>[{"id"=>"M12701", "name"=>"Obesity", "asFound"=>"Obesity", "relevance"=>"HIGH"}, {"id"=>"M23005", "name"=>"Metabolic Syndrome", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M12702", "name"=>"Obesity, Morbid", "asFound"=>"Obesity, Morbid", "relevance"=>"HIGH"}, {"id"=>"M26186", "name"=>"Overweight", "relevance"=>"LOW"}, {"id"=>"M25307", "name"=>"Overnutrition", "relevance"=>"LOW"}, {"id"=>"M12684", "name"=>"Nutrition Disorders", "relevance"=>"LOW"}, {"id"=>"M5114", "name"=>"Body Weight", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"endoscopic reduction of ghrelin rich gastric mucosa either with\n\n1. band ligation (group 1; n=16) and diet control\n2. argon plasma mediated reduction and diet control (group 2; n=16)\n3. control group exposed to low caloric diet and exercise (group 3; n=16)."}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>48}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-12-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-12-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-19", "studyFirstSubmitDate"=>"2022-06-30", "studyFirstSubmitQcDate"=>"2024-01-19", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-09-13", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Number of patients with improved insulin resistance", "timeFrame"=>"6 months", "description"=>"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"}], "primaryOutcomes"=>[{"measure"=>"Number of patients with significant weight reduction", "timeFrame"=>"6 month", "description"=>"significant weight reduction of more than 10% of baseline body weight measured in kilograms"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Obesity, Morbid", "Endoscopy"]}, "descriptionModule"=>{"briefSummary"=>"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.\n\nGhrelin 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.", "detailedDescription"=>"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.\n\nAlterations 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.\n\nLow systemic ghrelin levels have been reported in untreated hyperthyroidism, in male hypogonadism, in the polycystic ovary syndrome, or after total gastrectomy \\[5, 6\\]."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"50 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* body mass index more than 25\n* diagnosis of diabetes mellitus.\n* diagnosis of cardio-metabolic syndrome.\n* fatty liver disease diagnosed by abdominal ultrasound.\n\nExclusion Criteria:\n\n* use of drugs which induce insulin resistance, diabetes and hepatic steatosis.\n* excess alcohol consumption.\n* chronic gastritis, active peptic ulcer.\n* malignancy.\n* depression and severe psychological disorders\n* inability to give informed consent.\n* coagulopathy (INR more than 1.5, platelets less than 50000 per cmm).\n* severe cardiopulmonary comorbidity."}, "identificationModule"=>{"nctId"=>"NCT06231251", "acronym"=>"ETO", "briefTitle"=>"Endoscopic Gastric Reduction of Gastric Mucosa in Obesity", "organization"=>{"class"=>"OTHER_GOV", "fullName"=>"Zagazig University"}, "officialTitle"=>"Impact of Endoscopic Gastric Reduction of Ghrelin Receptors Rich Gastric Mucosa on Obesity and Metabolic Syndrome: a Randomized Controlled Trial", "orgStudyIdInfo"=>{"id"=>"9352"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"control group", "description"=>"exposed to low caloric diet (15 calories/kilogram) and exercise", "interventionNames"=>["Other: upper gastrointestinal endoscopy"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"endoscopic band ligation", "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", "interventionNames"=>["Other: upper gastrointestinal endoscopy"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"endoscopic argon plasma coagulation", "description"=>"argon plasma mediated reduction of gastric mucosa rich in ghrelin receptors by appling argon to stomach mucosa from fundus to mid body", "interventionNames"=>["Other: upper gastrointestinal endoscopy"]}], "interventions"=>[{"name"=>"upper gastrointestinal endoscopy", "type"=>"OTHER", "description"=>"reduction of ghrelin rich gastric mucosa with band ligation or argon plasma", "armGroupLabels"=>["control group", "endoscopic argon plasma coagulation", "endoscopic band ligation"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"44519", "city"=>"Zagazig", "state"=>"Sharkia", "status"=>"RECRUITING", "country"=>"Egypt", "contacts"=>[{"name"=>"Waseem Seleem, md", "role"=>"CONTACT", "email"=>"waseemmohamed1975@gmail.com", "phone"=>"+201025264008"}, {"name"=>"Amr Hanafy, md", "role"=>"CONTACT", "email"=>"dr_amr_hanafy@yahoo.com", "phone"=>"+201100061861"}], "facility"=>"Zagazig University", "geoPoint"=>{"lat"=>30.58768, "lon"=>31.502}}], "centralContacts"=>[{"name"=>"Amr S Hanafy", "role"=>"CONTACT", "email"=>"amrhanafy@zu.edu.eg", "phone"=>"+201100061861"}, {"name"=>"waseem seleem", "role"=>"CONTACT"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Zagazig University", "class"=>"OTHER_GOV"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"professor of medicine and gastroenterology", "investigatorFullName"=>"Amr Shaaban Hanafy", "investigatorAffiliation"=>"Zagazig University"}}}}
