Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-01-24 @ 11:13 PM
Study NCT ID:
NCT04028193
Status:
UNKNOWN
Last Update Posted:
2022-11-15
First Post:
2019-07-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fat Supplementation on Dumping Syndrome Associated Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004377', 'term': 'Dumping Syndrome'}], 'ancestors': [{'id': 'D011178', 'term': 'Postgastrectomy Syndromes'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004736', 'term': 'Energy-Generating Resources'}], 'ancestors': [{'id': 'D004777', 'term': 'Environment'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-12', 'studyFirstSubmitDate': '2019-07-15', 'studyFirstSubmitQcDate': '2019-07-18', 'lastUpdatePostDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucose Levels', 'timeFrame': 'before the ingestion of the carbohydrate and fat supplement (baseline)', 'description': 'Blood glucose measurement'}, {'measure': 'Glucose Levels', 'timeFrame': '30 minutes after the ingestion of the carbohydrate and fat supplement', 'description': 'Blood glucose measurement'}, {'measure': 'Glucose Levels', 'timeFrame': '60 minutes after the ingestion of the the carbohydrate and fat supplement', 'description': 'Blood glucose measurement'}, {'measure': 'Glucose Levels', 'timeFrame': '90 minutes after the ingestion of the the carbohydrate and fat supplement', 'description': 'Blood glucose measurement'}, {'measure': 'Glucose Levels', 'timeFrame': '120 minutes after the ingestion of the the carbohydrate and fat supplement', 'description': 'Blood glucose measurement'}, {'measure': "Sigstad's Questionnaire", 'timeFrame': '1st hour after the ingestion of the supplements', 'description': 'Dumping syndrome symptom associated questionnaire'}, {'measure': "Sigstad's Questionnaire", 'timeFrame': '2nd hour after the ingestion of the supplements', 'description': 'Dumping syndrome symptom associated questionnaire'}, {'measure': "Arts's Questionnaire", 'timeFrame': '1st hour after the ingestion of the supplements', 'description': 'Dumping syndrome symptom associated questionnaire'}, {'measure': "Arts's Questionnaire", 'timeFrame': '2nd hour after the ingestion of the supplements', 'description': 'Dumping syndrome symptom associated questionnaire'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dumping syndrome', 'Fat supplement', 'post bariatric surgery'], 'conditions': ['Dumping Syndrome']}, 'descriptionModule': {'briefSummary': "The purpose of the study is the investigation of the effect of fat supplement on gastric emptying rate and the appearance of symptoms of Dumping Syndrome in patients who have undergone gastrointestinal- duodenal surgery. Patients who have undergone bariatric surgery have been examined for the presence of the Dumping syndrome, with glucose measurements, the Sigstad's questionnaire and questionnaire of Arts. Patients diagnosed positive, reiterated the examination process in a second meeting consuming an extra fat supplement. The data obtained on the different appointments were compared between the two groups in a cross over design."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Dumping Syndrome\n\nExclusion Criteria:\n\n* Patients with diabetes mellitus type 1 and 2, Patients with impaired balance of fluids and electrolytes, Patients on diuretics pills or corticosteroids or hypoglycemic tablets and Insulin.'}, 'identificationModule': {'nctId': 'NCT04028193', 'acronym': 'Fat on DS', 'briefTitle': 'Fat Supplementation on Dumping Syndrome Associated Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Technological Educational Institute of Thessaly'}, 'officialTitle': 'The Effect of Fat Supplementation on the Appearance of Symptoms Associated With Dumping Syndrome in Patients Undergone Bariatric Surgery', 'orgStudyIdInfo': {'id': '5411069DD0467'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Diagnose Dumping after supplement consumption', 'description': 'Carbohydrate ingestion to provoke dumping syndrome related symptoms', 'interventionNames': ['Dietary Supplement: Resource Energy']}, {'type': 'OTHER', 'label': 'Fat supplementation', 'description': 'A high fat supplement was added to the carbohydrate liquid meal that was previously used for diagnosis.', 'interventionNames': ['Dietary Supplement: Calogen']}], 'interventions': [{'name': 'Calogen', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Calogen fat supplement'], 'description': 'Polyunsaturated liquid fat supplement', 'armGroupLabels': ['Fat supplementation']}, {'name': 'Resource Energy', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Carbohydrate Supplement', 'armGroupLabels': ['Diagnose Dumping after supplement consumption']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56533', 'city': 'Thessaloniki', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'NIKOLETA CHATZIPAPA', 'role': 'CONTACT', 'email': 'nikoletaxatzhpapa@hotmail.com'}, {'name': 'DEMETRA HARITOU', 'role': 'CONTACT', 'email': 'dharitou@yahoo.gr'}, {'name': 'Demetra Haritou', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nikoleta Chatzipapa', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nikoleta Chatzipapa', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'centralContacts': [{'name': 'NIKOLETA CHATZIPAPA', 'role': 'CONTACT', 'email': 'nikoletaxatzhpapa@hotmail.com', 'phone': '00306982484394'}, {'name': 'DEMETRA HARITOU', 'role': 'CONTACT', 'email': 'dharitou@yahoo.gr', 'phone': '00306973240203'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technological Educational Institute of Thessaly', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Associate University of Thessaly', 'investigatorFullName': 'Chatzipapa Nikoleta', 'investigatorAffiliation': 'University of Thessaly'}}}}