Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-28 @ 7:11 PM
Study NCT ID:
NCT01366794
Status:
COMPLETED
Last Update Posted:
2014-03-17
First Post:
2011-05-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Macronutrients and Gut Hormone Secretion
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': 'D000078622', 'term': 'Nutrients'}, {'id': 'D005947', 'term': 'Glucose'}, {'id': 'C545823', 'term': 'soybean oil, phospholipid emulsion'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-14', 'studyFirstSubmitDate': '2011-05-31', 'studyFirstSubmitQcDate': '2011-06-02', 'lastUpdatePostDateStruct': {'date': '2014-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Release of gut hormones', 'timeFrame': '300 min'}], 'secondaryOutcomes': [{'measure': 'Insulin secretion', 'timeFrame': '300 min'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Gut hormones', 'Insulin secretion'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'Study hypothesis is to examine the relative contribution of macronutrients for gut hormone secretion after a mixed meal in healthy volunteers and in subjects with type 2 diabetes. Individual macronutrients or a mixed meal will therefore be served and gut hormones are measured during the following 300 min.', 'detailedDescription': 'In healthy volunteers and subjects with dietary regulated diabetes mellitus, glucose, protein mixture or fat emulsion will be served individually and on a separate occasions a mixed meal will be served. Samples will be taken during the following 300 min. Concentrations of the gut hormones glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1, insulin and glucagon will be determined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy status or type 2 diabetes with dietary regulation\n\nExclusion Criteria:\n\n* Liver disease\n* kidney disease\n* thyroid disease'}, 'identificationModule': {'nctId': 'NCT01366794', 'briefTitle': 'Macronutrients and Gut Hormone Secretion', 'organization': {'class': 'OTHER', 'fullName': 'Lund University'}, 'officialTitle': 'Effects of Macronutrients on Gut Hormone and Islet Hormone Secretion in Healthy Volunteers and Type 2 Diabetes', 'orgStudyIdInfo': {'id': '005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Type 2 diabetes', 'description': 'Administration of macronutrients in type 2 diabetes', 'interventionNames': ['Other: Macronutrients']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy volunteers', 'description': 'Administration of macronutrients in healthy volunteers', 'interventionNames': ['Other: Macronutrients']}], 'interventions': [{'name': 'Macronutrients', 'type': 'OTHER', 'otherNames': ['Glucose', 'Protein mixture', 'Fat emulsion', 'Mixed meal'], 'description': 'Glucose 330 kcal Protein 110 kcal Fat emulsion 110 kcal Mixed meal 550 kcal', 'armGroupLabels': ['Healthy volunteers', 'Type 2 diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '221 84', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Department of Clinical Sciences Lund, Lund University', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'zip': '22184', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Lund University', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Bo Ahrén, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lund University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lund University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Bo Ahren', 'investigatorAffiliation': 'Lund University'}}}}