Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-29 @ 7:37 AM
Study NCT ID:
NCT01554566
Status:
COMPLETED
Last Update Posted:
2012-03-15
First Post:
2012-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic Effects of Honey in Type 1 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006722', 'term': 'Honey'}, {'id': 'C509819', 'term': 'pteropsin, Apis mellifera'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-14', 'studyFirstSubmitDate': '2012-03-09', 'studyFirstSubmitQcDate': '2012-03-14', 'lastUpdatePostDateStruct': {'date': '2012-03-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum lipids', 'timeFrame': '12 wk', 'description': 'Fasting serum lipids (cholesterol, triglycerides, low density lipoprotein cholesterol and high density lipoprotein cholesterol) were measured at base line, cross over (12 wk) and end point of the study (24 wk)'}], 'secondaryOutcomes': [{'measure': 'C-peptide', 'timeFrame': '12 week', 'description': 'Fasting and 2 hr postprandial C-peptide were measured at base line, cross over (12 wk) and end point of the study (24 wk)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['honey', 'diabetes', 'lipids', 'c-peptide'], 'conditions': ['Type 1 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '23256446', 'type': 'DERIVED', 'citation': 'Abdulrhman MM, El-Hefnawy MH, Aly RH, Shatla RH, Mamdouh RM, Mahmoud DM, Mohamed WS. Metabolic effects of honey in type 1 diabetes mellitus: a randomized crossover pilot study. J Med Food. 2013 Jan;16(1):66-72. doi: 10.1089/jmf.2012.0108. Epub 2012 Dec 20.'}], 'seeAlsoLinks': [{'url': 'http://med.shams.edu.eg/', 'label': 'Faculty of medicine, Ain Shams University, Egypt'}]}, 'descriptionModule': {'briefSummary': 'This study aimed at evaluation of the metabolic effects of honey, as a supplemental food, in patients suffering from type 1 diabetes mellitus. A crossover design (two 12-weeks intervention periods) was used to measure honey effects. The subjects were randomized into two groups (intervention to control \\[I/C\\] and control to intervention \\[C/I\\] groups. Each group consisted of 10 patients. . The subjects in the I/C group consumed 0.5 ml honey/kg/day in the first 12-week period (period 1) while the subjects in the C/I group did not receive honey as a control in period 1. After period 1 the subjects of each group exchanged their protocol for the following 12-week period (period 2).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with type 1 diabetes mellitus with their last HbA1C less than 10% were candidates for this study.\n\nExclusion Criteria:\n\n* Coexisting renal or hepatic impairment\n* Coexisting diseases e.g., malignancy, other endocrine disorders\n* Patients on steroid therapy or other drugs that may affect the body weight or serum lipids.'}, 'identificationModule': {'nctId': 'NCT01554566', 'briefTitle': 'Metabolic Effects of Honey in Type 1 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Metabolic Effects of Honey in Type 1 Diabetes Mellitus: a Cross Over Randomised Controlled Pilot Study', 'orgStudyIdInfo': {'id': 'honey1010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'honey, no honey', 'interventionNames': ['Dietary Supplement: honey']}], 'interventions': [{'name': 'honey', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['bee honey'], 'description': 'The subjects in the I/C group consumed 0.5 ml honey/kg/day in the first 12-week period (period 1) while the subjects in the C/I group did not receive honey as a control in period 1. After period 1 the subjects of each group exchanged their protocol for the following 12-week period (period 2).', 'armGroupLabels': ['honey, no honey']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Kasr El Ainy', 'country': 'Egypt', 'facility': 'National Institute of Diabetes and Endocrinology', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Mamdouh AM Abdulrhman, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'pediatric department, faculty of medicine, ain shams university'}, {'name': 'Mohamed H El Hefnawy, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'national institute of diabetes and endocrinology, cairo, egypt'}, {'name': 'Rasha H Aly, assist. prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'pediatric department, faculty of medicine, ain shams university'}, {'name': 'Rania H Shatla, lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'pediatric department, faculty of medicine, ain shams university'}, {'name': 'Doaa M Mohamed, M.B.B.Ch', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'pediatric department, faculty of medicine, ain shams university'}, {'name': 'Waheed S Mohamed, M.B.B.Ch', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'pediatric department, faculty of medicine, ain shams university'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'mamdouh abdulmaksoud abdulrhman', 'investigatorAffiliation': 'Ain Shams University'}}}}