Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-31 @ 3:46 PM
Study NCT ID:
NCT01010594
Status:
TERMINATED
Last Update Posted:
2013-03-21
First Post:
2009-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Two Pieces of Fruit to Type 2 Diabetics?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'whyStopped': 'PI changed job and project was not economically viable and therefor terminated', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-20', 'studyFirstSubmitDate': '2009-11-09', 'studyFirstSubmitQcDate': '2009-11-09', 'lastUpdatePostDateStruct': {'date': '2013-03-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Hba1c', 'timeFrame': 'three months'}], 'secondaryOutcomes': [{'measure': 'change in bodyweight', 'timeFrame': 'three months'}, {'measure': 'change in serum lipids', 'timeFrame': 'three months'}, {'measure': 'change in fruit intake', 'timeFrame': 'three months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '23497350', 'type': 'RESULT', 'citation': 'Christensen AS, Viggers L, Hasselstrom K, Gregersen S. Effect of fruit restriction on glycemic control in patients with type 2 diabetes--a randomized trial. Nutr J. 2013 Mar 5;12:29. doi: 10.1186/1475-2891-12-29.'}]}, 'descriptionModule': {'briefSummary': "It has been questioned whether patients with type 2 diabetes who are advised to restrict their fruit consumption to two or less pieces of fruits daily have better outcomes (HbA1c, body weight, fruit intake and serum lipids) after three months compared to patients with type 2 diabetes who are advised to eat at least two pieces of fruits.\n\nTo the investigators' knowledge, no randomized controlled trial has evaluated this.\n\nThe investigators therefore perform a randomized controlled trial including 76 patients with type 2 diabetes to investigate this.\n\nThe investigators' hypothesis is that:\n\nType 2 diabetics who are advised to restrict their fruit consumption have the same Hba1c three months after an initially dietary treatment as type 2 diabetics who are advised not to restrict their fruit consumption."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients refered from a general practitioner\n\nExclusion Criteria:\n\n* no Hba1c when refered\n* Hba1c lower than 5% or higher than 12%\n* patients that require a translator\n* patients with severe cardiovascular, renal or endocrine disease\n* psychiatric patients\n* pregnant patients'}, 'identificationModule': {'nctId': 'NCT01010594', 'briefTitle': 'Two Pieces of Fruit to Type 2 Diabetics?', 'organization': {'class': 'OTHER', 'fullName': 'Hospitalsenheden Vest'}, 'officialTitle': 'Two Pieces of Fruit to Type 2 Diabetics?', 'orgStudyIdInfo': {'id': 'M-20090183'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fruit restricted', 'description': 'Type 2 diabetics are advised to restrict their fruit intake to two pieces or less daily.', 'interventionNames': ['Behavioral: dietary treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fruit ad libitum', 'description': 'Type 2 diabetics are advised to eat at least two pieces of fruits daily', 'interventionNames': ['Behavioral: dietary treatment']}], 'interventions': [{'name': 'dietary treatment', 'type': 'BEHAVIORAL', 'description': 'A standard dietary treatment except that they are advised to restrict their fruit intake.', 'armGroupLabels': ['Fruit restricted']}, {'name': 'dietary treatment', 'type': 'BEHAVIORAL', 'description': 'A standard dietary treatment.', 'armGroupLabels': ['Fruit ad libitum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7500', 'city': 'Holstebro', 'state': 'Holstebro', 'country': 'Denmark', 'facility': 'Department of nutrition, Regional Hospital West Jutland', 'geoPoint': {'lat': 56.36009, 'lon': 8.61607}}], 'overallOfficials': [{'name': 'Allan S Christensen, MHSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Department of Endocrinology and Metabolism, Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospitalsenheden Vest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MHSc, RD', 'investigatorFullName': 'Allan Stubbe Christensen', 'investigatorAffiliation': 'Hospitalsenheden Vest'}}}}