Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2026-03-08 @ 11:22 PM
Study NCT ID:
NCT04166760
Status:
COMPLETED
Last Update Posted:
2020-11-06
First Post:
2019-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic Effects of Whey Compounds in Patients With Diabetes Mellitus Type 2.
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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Double blinded, randomized, crossover design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-05', 'studyFirstSubmitDate': '2019-11-14', 'studyFirstSubmitQcDate': '2019-11-14', 'lastUpdatePostDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in iAUC for insulin between WHE and speWHE', 'timeFrame': 'OGTT, 3 hours.', 'description': 'Difference in iAUC for insulin between WHE and speWHE'}], 'secondaryOutcomes': [{'measure': 'Differences in iAUC and concentration differences for GIP', 'timeFrame': 'OGTT 3 hours'}, {'measure': 'Differences in iAUC and concentration differences for GLP-1', 'timeFrame': 'OGTT 3 hours'}, {'measure': 'Differences in iAUC and concentration differences for glucagon', 'timeFrame': 'OGTT 3 hours'}, {'measure': 'Differences in iAUC and concentration differences for glucose', 'timeFrame': 'OGTT 3 hours'}, {'measure': 'Differences in iAUC and concentration differences for C-peptid', 'timeFrame': 'OGTT 3 hours'}, {'measure': 'Differences in iAUC and concentration differences for FFA', 'timeFrame': 'OGTT 3 hours'}, {'measure': 'Activity measurements', 'timeFrame': '5 days'}, {'measure': 'continuous glucose measurement (CGM)', 'timeFrame': '5 days', 'description': 'CGM with time in normal range 4-10 mmol/l, peak after a meal, AUC in the days with the interventions.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The main objective of our study is to investigate the metabolic effects of a i) ordinary whey protein (WHE) and ii) a specific whey protein fraction (speWHE) when the interventions are ingested by patients with type 2 diabetes 30 minutes prior to an oral glucose tolerance test (OGTT). We will also investigate the glucose response when the patients ingest the interventions at home in their own environment 30 minutes before breakfast and dinner (2days) and also monitor glucose levels without interventions (2 days).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Type 2 diabetes (T2D) diagnosis\n* No medical treatment or metformin/sulfonylureas(SU) alone in the treatment of T2D\n* No daily use of protein drinks\n* Hba1c between 40 mmol/mol and 69 mmol/mol\n* 20 kg/m2 \\< BMI \\< 35 kg/m2\n* Screening blood test: 1200 pmol/l \\> C-peptid \\> 370 pmol/l\n\nExclusion Criteria:\n\n* Other diabetes medication than metformin/SU (e.g. insulin, GLP-1 analog, DPP-4 inhibitor, SGLT2-inhibitor)\n* Affected screening blood test assessed by the primary investigator(PI)/sponsor\n* Does not understand or speak danish\n* Milk allergy\n* PI finds the patient not fit (e.g. mental illness, too nervous or other)'}, 'identificationModule': {'nctId': 'NCT04166760', 'briefTitle': 'Metabolic Effects of Whey Compounds in Patients With Diabetes Mellitus Type 2.', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Metabolic Effects of Whey Compounds in Patients With Diabetes Mellitus Type 2.', 'orgStudyIdInfo': {'id': 'TAKE4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'WHE (regular whey protein)', 'description': "Regular whey protein. The intervention will be ingested 30 min. prior to an OGTT (3 hours). The intervention will also be ingested 30 min prior to breakfast and dinner for 2 days in the patient's own environment.", 'interventionNames': ['Dietary Supplement: WHE']}, {'type': 'EXPERIMENTAL', 'label': 'speWHE (specific whey protein compound)', 'description': "Specific whey protein compound. The intervention will be ingested 30 min. prior to an OGTT (3 hours). The intervention will also be ingested 30 min prior to breakfast and dinner for 2 days in the patient's own environment.", 'interventionNames': ['Dietary Supplement: speWHE']}], 'interventions': [{'name': 'speWHE', 'type': 'DIETARY_SUPPLEMENT', 'description': '25 gram of a specific whey fraction (confidential)', 'armGroupLabels': ['speWHE (specific whey protein compound)']}, {'name': 'WHE', 'type': 'DIETARY_SUPPLEMENT', 'description': '25 gram protein of a regular whey compound', 'armGroupLabels': ['WHE (regular whey protein)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Medicinsk forskningslaboratorium for Diabetes og Hormonsygdomme og Steno Diabetes Center Aarhus (M-lab), Aarhus universitetshospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Niels Jessen, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medicinsk forskningslaboratorium for Diabetes og Hormonsygdomme og Steno Diabetes Center Aarhus (M-lab), Aarhus universitetshospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}