Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2026-01-02 @ 12:07 AM
Study NCT ID:
NCT05129735
Status:
WITHDRAWN
Last Update Posted:
2024-08-23
First Post:
2021-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Exploratory Investigation to Assess Changes in Quality of Life for Individuals With Type 2 Diabetes After Taking a Meal-replacement Shake.
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is an open-label single-arm observational trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Sponsor withdrawn', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-09-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-21', 'studyFirstSubmitDate': '2021-11-03', 'studyFirstSubmitQcDate': '2021-11-18', 'lastUpdatePostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of quality of life score from baseline to 12-weeks', 'timeFrame': '12 weeks', 'description': 'Survey based quality of life measure on a scale from 0-5 (0=lowest possible score, 5=highest possible score)'}], 'secondaryOutcomes': [{'measure': 'Improvement in a1c levels from baseline to 12-weeks', 'timeFrame': '12 weeks', 'description': 'Change in a1c biomarkers measured with an at-home blood test after 12 weeks compared to baseline results.'}, {'measure': 'Improvement in blood glucose from baseline to 12-weeks', 'timeFrame': '12 weeks', 'description': 'Change in blood glucose biomarkers measured with an at-home blood test after 12 weeks compared to baseline results.'}, {'measure': 'Improvement in insulin levels from baseline to 12-weeks', 'timeFrame': '12 weeks', 'description': 'Change in insulin levels measured with an at-home blood test after 12 weeks compared to baseline results.'}, {'measure': 'Improvement in total cholesterol levels from baseline to 12-weeks', 'timeFrame': '12 weeks', 'description': 'Change in total cholesterol measured with an at-home blood test after 12 weeks compared to baseline results.'}, {'measure': 'Improvement in triglyceride levels from baseline to 12-weeks', 'timeFrame': '12 weeks', 'description': 'Change in triglyceride measured with an at-home blood test after 12 weeks compared to baseline results.'}, {'measure': 'Improvement in HDL cholesterol levels from baseline to 12-weeks', 'timeFrame': '12 weeks', 'description': 'Change in HDL cholesterol measured with an at-home blood test after 12 weeks compared to baseline results.'}, {'measure': 'Improvement in LDL cholesterol levels from baseline to 12-weeks', 'timeFrame': '12 weeks', 'description': 'Change in LDL cholesterol measured with an at-home blood test after 12 weeks compared to baseline results.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'This is an open-label single-arm observational trial to study the effectiveness of a commercially available meal-replacement shake and its effect on the quality of life in individuals with type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or Female between 18-75 years old\n* Diagnosed with type 2 diabetes for at least 3 months\n* HbA1c of 7.5 to 10% inclusive\n* BMI of 27 to 40 kg/m2\n* If on any medication, treated with a stable dose for at least 90 days\n* Must be in good health (don't report any medical conditions asked in the screening questionnaire)\n* Willing and able to provide written informed consent\n* Must have a Glucometer at home\n\nExclusion Criteria:\n\n* Diagnosis of type 1 diabetes\n* Have a history of severe hypoglycemia or hyperglycemia requiring hospitalization within the prior 6 months\n* Use of dietary supplements or meal-replacement shakes targeted at diabetes and unwilling to stop using them for the duration of the study\n* Allergies to any test product ingredients\n* Has any of the following medical conditions:\n* Oncological conditions\n* Psychiatric disease\n* Cardiovascular disease: any hospitalization within the past 3 months\n* Multiple Sclerosis\n* Gastrointestinal conditions such as Celiac disease, Crohn's disease, etc.\n* Any other severe chronic disease\n* History of drug or alcohol abuse\n* Females who are pregnant, want to become pregnant for the duration of the study, or who are breastfeeding during the course of the study\n* Participation in a clinical research trial within 30 days prior to screening\n* Participating in an investigational health product research study\n* Any disorder, unwillingness, or inability, which in the investigator's opinion, might jeopardize the individual's safety or compliance with the protocol"}, 'identificationModule': {'nctId': 'NCT05129735', 'briefTitle': 'An Exploratory Investigation to Assess Changes in Quality of Life for Individuals With Type 2 Diabetes After Taking a Meal-replacement Shake.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teatis, Inc'}, 'officialTitle': 'An Exploratory Investigation to Assess Changes in Quality of Life for Individuals With Type 2 Diabetes After Taking a Meal-replacement Shake.', 'orgStudyIdInfo': {'id': '20227Teatis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Meal replacement shake', 'description': 'Teatis meal replacement shake', 'interventionNames': ['Dietary Supplement: Meal replacement shake']}], 'interventions': [{'name': 'Meal replacement shake', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Each day for the study period (12 weeks), the participants will take one meal-replacement shake per day for breakfast. The breakfast will be replaced by the shake entirely.', 'armGroupLabels': ['Meal replacement shake']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Citruslabs', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}], 'overallOfficials': [{'name': 'Susanne Mitschke, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Citruslabs'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teatis, Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Citruslabs', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}