Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-03-12 @ 4:54 AM
Study NCT ID:
NCT02813759
Status:
COMPLETED
Last Update Posted:
2016-06-27
First Post:
2016-06-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sucralose in Subjects With Diabetes Mellitus Insulin Requesting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C026285', 'term': 'trichlorosucrose'}, {'id': 'D014867', 'term': 'Water'}], 'ancestors': [{'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-22', 'studyFirstSubmitDate': '2016-06-16', 'studyFirstSubmitQcDate': '2016-06-22', 'lastUpdatePostDateStruct': {'date': '2016-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycemia', 'timeFrame': 'up to 120 minutes', 'description': 'Glycemia (mg/dL) to -15, 30, 60 and 120 minutes, with respect to breakfast intake.'}, {'measure': 'C peptide', 'timeFrame': 'up to 60 minutes', 'description': 'C-peptide at -15 and 60 minutes with respect to breakfast intake'}, {'measure': 'Satiety', 'timeFrame': 'up to 120 minutes', 'description': 'Visual Analog Scale (VAS) was applied immediate and tardy postprandial (two hours after eating breakfast).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['GLYCEMIA', 'SATIETY', 'C PEPTIDE', 'PRELOAD', 'INSULIN'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '32449201', 'type': 'DERIVED', 'citation': 'Lohner S, Kuellenberg de Gaudry D, Toews I, Ferenci T, Meerpohl JJ. Non-nutritive sweeteners for diabetes mellitus. Cochrane Database Syst Rev. 2020 May 25;5(5):CD012885. doi: 10.1002/14651858.CD012885.pub2.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the acute effect of a preload of sucralose in presence of carbohydrate (HC) available on the glycemic response, postprandial C peptide and satiety in patients with type 2 diabetes mellitus (DM2) in intensive insulin therapy (IIT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minimum period of six month intensive insulin therapy\n* Prescription rapid insulin in the breakfast\n* Aged 35 to 70 years\n* BMI 25 to 39.9 kg / m2\n* HbA1c lower than or equal to 10% (86 mmol / mol)\n* Menopausal women under hormone replacement therapy\n\nExclusion Criteria:\n\n* History of intolerance artificial sweetener sucralose\n* Pregnant women\n* Puerperal women\n* Subjects with neurological disease, endocrine disorder no treatment, kidney disease stage IV or V, cancer, liver disease, chronic obstructive pulmonary disease, HIV\n* Subjects with history of stroke , acute myocardial infarction and gastrointestinal resection'}, 'identificationModule': {'nctId': 'NCT02813759', 'acronym': 'SDMIR', 'briefTitle': 'Sucralose in Subjects With Diabetes Mellitus Insulin Requesting', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Valparaiso'}, 'officialTitle': 'Effect of a Sucralose Preload on Postprandial Metabolic Parameters and Satiety in Subjects With Type 2 Diabetes Mellitus Under Intensive Insulin Therapy - Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '17/2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sucralose', 'description': '14 mg sucralose (Zero K sucralose powder, IANSA®) an 200 mL of water', 'interventionNames': ['Other: Sucralose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Water', 'description': '200 mL of water', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Sucralose', 'type': 'OTHER', 'description': 'Subjects drank 200 mL of water with 14 mg sucralose, followed by a standard breakfast.', 'armGroupLabels': ['Sucralose']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Water'], 'description': 'Subjects drank 200 mL of water alone (placebo), followed by a standard breakfast.', 'armGroupLabels': ['Water']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Valparaiso', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nutritionist', 'investigatorFullName': 'Claudia Vega Soto', 'investigatorAffiliation': 'Universidad de Valparaiso'}}}}