Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-01-10 @ 11:14 PM
Study NCT ID:
NCT01954667
Status:
COMPLETED
Last Update Posted:
2013-10-07
First Post:
2013-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anthropometric Measures and Severity of Gastroesophageal Reflux Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'targetDuration': '6 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-29', 'studyFirstSubmitDate': '2013-09-29', 'studyFirstSubmitQcDate': '2013-09-29', 'lastUpdatePostDateStruct': {'date': '2013-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of anthropometric measures on GERD', 'timeFrame': '1 year', 'description': 'evaluate the impact of different anthropometric measures on clinical and endoscopic severity of GERD and its relation to serum leptin.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gastroesophageal Reflux Disease; Anthropometric Measures; Leptin'], 'conditions': ['Gastroesophageal Reflux Disease']}, 'descriptionModule': {'briefSummary': 'evaluate the impact of different anthropometric measures on clinical and endoscopic severity of GERD and its relation to serum leptin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This prospective, case-controlled study included 60 Egyptian patients who attended Ain Shams University Hospitals and Theodor Bilharz Research Institute; Cairo, Egypt', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gastro esophageal reflux symptoms (e.g. heart burn, regurgitation, water brash or atypical symptoms such as hoarseness of voice, asthma and cough)\n* complete upper gastrointestinal endoscopy.\n\nExclusion Criteria:\n\n* Receiving medication for reflux disease (including proton pump inhibitor, histamine type 2 receptors blocker, prokinetic agents) in the previous month.\n* Pregnant woman.\n* History of upper abdominal surgery.\n* Severe co-morbidity as cirrhosis, end-stage renal disease and heart failure.'}, 'identificationModule': {'nctId': 'NCT01954667', 'briefTitle': 'Anthropometric Measures and Severity of Gastroesophageal Reflux Disease', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'orgStudyIdInfo': {'id': 'Anthropometric Measures &GERD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'obese and overweight', 'description': 'Group1 (n=30): overweight and obese (BMI ≥25 and/ or WHtR≥0.5)'}, {'label': 'average body weight', 'description': 'Group2 (n=30): normal weight (BMI ≥ 18 to \\< 25 and/or WHtR ≥0.4 to \\<0.5)'}, {'label': 'Control group', 'description': 'Control Group (n= 20): healthy subjects, matched for age and gender, were included in this study. All included controls had average weight (BMI ≥ 18 to \\< 25 and/ or WHtR ≥0.4 to \\<0.5)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Tropical medicine department', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of tropical medicine , Ain Shams university', 'investigatorFullName': 'Iman Fawzy Montasser', 'investigatorAffiliation': 'Ain Shams University'}}}}