Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT01034618
Status:
COMPLETED
Last Update Posted:
2009-12-17
First Post:
2009-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Protein Hydrolyzation and Glycemic Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-16', 'studyFirstSubmitDate': '2009-12-16', 'studyFirstSubmitQcDate': '2009-12-16', 'lastUpdatePostDateStruct': {'date': '2009-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucose and insulin homeostasis.'}], 'secondaryOutcomes': [{'measure': 'Plasma amino acid profiles'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes', 'protein', 'protein hydrolysate'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'The insulinotropic effects of protein hydrolysate/amino acid ingestion have been shown to regulate blood glucose homeostasis in both type 2 diabetes patients and normoglycemic controls. The objective of the study is to investigate the optimal dose of such an insulinotropic mixture.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male\n* Age between 40 and 70 years\n* Oral blood glucose lowering medication\n* BMI \\< 35 kg/m2\n\nExclusion Criteria:\n\n* Exogenous insulin use\n* Cardiac disease (any cardiac event in the last 5 years)\n* Diabetic complications (microvascular complications, microalbuminuria: albumin:creatinine ratio \\>2,5)'}, 'identificationModule': {'nctId': 'NCT01034618', 'briefTitle': 'Protein Hydrolyzation and Glycemic Control', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'The Additional Effects of Protein Hydrolysate Supplementation on Glucose Homeostasis in Type 2 Diabetes', 'orgStudyIdInfo': {'id': '06-3-081'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: Protein hydrolyzation']}, {'type': 'EXPERIMENTAL', 'label': 'Intact protein', 'interventionNames': ['Dietary Supplement: Protein hydrolyzation']}, {'type': 'EXPERIMENTAL', 'label': 'Protein hydrolysate', 'interventionNames': ['Dietary Supplement: Protein hydrolyzation']}], 'interventions': [{'name': 'Protein hydrolyzation', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Intact protein', 'Placebo', 'Protein hydrolysate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6229ER', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Center+', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Ralph J.F. Manders, PhD', 'oldOrganization': 'Maastricht University Medical Center'}}}}