Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-01-04 @ 12:09 AM
Study NCT ID:
NCT01522157
Status:
COMPLETED
Last Update Posted:
2013-12-02
First Post:
2012-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Cross-over Trial of the Postprandial Effects of Three Different Diets in Patients With Type 2 Diabetes
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018752', 'term': 'Diet, Fat-Restricted'}, {'id': 'D050528', 'term': 'Diet, Carbohydrate-Restricted'}, {'id': 'D038441', 'term': 'Diet, Mediterranean'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D000095500', 'term': 'Diet, Plant-Based'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-29', 'studyFirstSubmitDate': '2012-01-17', 'studyFirstSubmitQcDate': '2012-01-30', 'lastUpdatePostDateStruct': {'date': '2013-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'P-glucose', 'timeFrame': '6 months', 'description': 'mmol/l'}, {'measure': 'P-Triglycerides', 'timeFrame': '6 months', 'description': 'mmol/l'}], 'secondaryOutcomes': [{'measure': 'P-Cholesterol', 'timeFrame': '6 months', 'description': 'mmol/l'}, {'measure': 'P-LDL-Cholesterol', 'timeFrame': '6 months', 'description': 'mmol/l'}, {'measure': 'P-HDL-Cholesterol', 'timeFrame': '6 months', 'description': 'mmol/l'}]}, 'conditionsModule': {'keywords': ['Diet', 'Low-carbohydrate', 'Postprandial', 'Type 2 diabetes mellitus'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '24312178', 'type': 'RESULT', 'citation': 'Fernemark H, Jaredsson C, Bunjaku B, Rosenqvist U, Nystrom FH, Guldbrand H. A randomized cross-over trial of the postprandial effects of three different diets in patients with type 2 diabetes. PLoS One. 2013 Nov 27;8(11):e79324. doi: 10.1371/journal.pone.0079324. eCollection 2013.'}]}, 'descriptionModule': {'briefSummary': 'The trial will study the acute metabolic effects of three different types of diet: low-fat diet, low-carbohydrate diet and Mediterranean diet. About 20 patients with diabetes mellitus type 2 will be recruited and each of them will be given each type of diet on three different days. Menus with the same energy content but with different content of fat, carbohydrate and protein are designed. Breakfast and lunch are served for the patients each day of testing. Laboratory samplings are performed six times during the day. The order of the dietary intervention is randomized for each patient.\n\nThe investigators suppose to find different reaction in plasma glucose and lipids depending on the type of diet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetes mellitus type 2\n\nExclusion Criteria:\n\n* Treatment with insulin or sulfonylurea'}, 'identificationModule': {'nctId': 'NCT01522157', 'briefTitle': 'A Randomized Cross-over Trial of the Postprandial Effects of Three Different Diets in Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Vårdcentralen Lyckorna'}, 'officialTitle': 'A Randomized Cross-over Trial of the Postprandial Effects of Three Different Diets in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'Dnr 2011/418-31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'All test patients', 'description': 'All test patients are given low-fat, low-carbohydrate and mediterranean diet, in randomised order on different days.', 'interventionNames': ['Dietary Supplement: Low-fat Diet', 'Dietary Supplement: Low-carbohydrate Diet', 'Dietary Supplement: Mediterranean Diet']}], 'interventions': [{'name': 'Low-fat Diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Low-fat Diet is provided for a breakfast and a lunch.', 'armGroupLabels': ['All test patients']}, {'name': 'Low-carbohydrate Diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Low-carbohydrate Diet is provided for a breakfast and a lunch.', 'armGroupLabels': ['All test patients']}, {'name': 'Mediterranean Diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Mediterranean Diet is provided for a breakfast and a lunch.', 'armGroupLabels': ['All test patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S-59183', 'city': 'Linköping', 'country': 'Sweden', 'facility': 'Department of Medical and Health Sciences, Linköping University', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}], 'overallOfficials': [{'name': 'Fredrik H Nystrom, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Endocrinology Linköping University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vårdcentralen Lyckorna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hans Guldbrand', 'investigatorAffiliation': 'Vårdcentralen Lyckorna'}}}}