Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-01-02 @ 1:49 AM
Study NCT ID:
NCT06810635
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-05
First Post:
2024-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Polyphenol Metabotypes in People with Diabetes 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059349', 'term': 'Urine Specimen Collection'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Stool Urine Plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2024-11-06', 'studyFirstSubmitQcDate': '2025-01-31', 'lastUpdatePostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in polyphenol metabolites in morning urine in persons with type 2 diabetes and in healthy controls.', 'timeFrame': 'This will be assessed the morning after ingestion of the pill containing polyphenols', 'description': 'The study aims to characterize the overall polyphenol metabotype in patients with T2DM compared to age-matched individuals without diabetes. For this purpose we will look at morning urine 24h after ingestion of a polyphenol rich pill.'}], 'secondaryOutcomes': [{'measure': 'Differences in polyphenol metabolites in 24h urine in persons with type 2 diabetes and in healthy controls.', 'timeFrame': 'Urine will be collected over a 24h period after ingestion of the polyphenol pill.', 'description': 'For this purpose participants will collect urine over a 24h period'}, {'measure': 'Transit time', 'timeFrame': 'baseline', 'description': 'Along with the ingestion of the polyphenol pill, people will consume E133, a food colorant that will also color the stool.'}, {'measure': 'the capacity of the gut microbiome to degrade polyphenols', 'timeFrame': 'baseline', 'description': 'By using a batch experiment.'}, {'measure': 'Metabolic health', 'timeFrame': 'baseline', 'description': 'This will be determined on the fasting blood samples'}, {'measure': 'lifestyle factors and medical history (A)', 'timeFrame': 'baseline', 'description': 'physical activity, using the validated IPAQ questionnaire'}, {'measure': 'lifestyle factors and medical history (B)', 'timeFrame': 'baseline', 'description': 'Sleep, using the validated PSQI questionnaire'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['polyphenol', 'transit time'], 'conditions': ['Type 2 Diabetes Mellitus (T2DM)']}, 'descriptionModule': {'briefSummary': 'This cross-sectional study seeks to characterize the overall polyphenol metabotype in patients with T2DM in comparison to age-matched individuals without diabetes. Additionally, the study aims to identify factors that influence the polyphenol metabotype (transit time and gut microbial capacity to degrade polyphenols in particular).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Flemish T2DM patients and controls from Ghent region.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all participants\n* between 40-85 years\n* age-matched individuals without diabetes\n* BMI between 18.5-30\n* no metabolic syndrome\n* persons with T2DM\n* at leats 2 years of clinical diagnoses of T2DM\n* stable medication use for at least 1 month\n\nExclusion Criteria:\n\n* pregnancy of breastfeeding\n* in last month\n* acute use of anti/pre/probiotics\n* start of new drug or dietary supplements\n* major changes in diet\n* major lifestyle changes\n* diseases\n* Gastrointestinal diseases (inflammatory bowel disease)\n* Bariatric surgery\n* Other forms of diabetes (cystic fibrosis/MODY/T1DM)\n* Heart problems (NYHA 3/4) or previous cardiovascular events\n* Liver problems: non-alcohol steatohepatitis (NASH) and cirrhosis\n* Lung problems (COPD - GOLD 3/4), cystic fibrosis\n* Uncontrolled thyroid function disruption in the past 6 months\n* Intake of coumarin derivatives and direct oral anticoagulant medication\n* Anti-cancer treatment: chemo-/immunotherapy\n* Immonosuppressants (transplant)\n* Antiepileptic drugs'}, 'identificationModule': {'nctId': 'NCT06810635', 'acronym': 'PPPIL', 'briefTitle': 'Polyphenol Metabotypes in People with Diabetes Type 2', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Polyphenol Metabotypes in People with Diabetes Type 2', 'orgStudyIdInfo': {'id': 'ONZ-2023-0601'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'T2DM', 'description': 'persons with type 2 diabetes mellitus', 'interventionNames': ['Dietary Supplement: Oral Polyphenol Challenge Test / PPPIL', 'Diagnostic Test: fasting blood sample', 'Diagnostic Test: Fasting urine collection', 'Diagnostic Test: 24 hours urine collection', 'Other: Questionnaires', 'Diagnostic Test: Stool collection', 'Diagnostic Test: Transit time determination']}, {'label': 'Non diabetic persons', 'description': 'This cohort is a group without type 2 diabetes or any other chronic illness', 'interventionNames': ['Dietary Supplement: Oral Polyphenol Challenge Test / PPPIL', 'Diagnostic Test: fasting blood sample', 'Diagnostic Test: Fasting urine collection', 'Diagnostic Test: 24 hours urine collection', 'Other: Questionnaires', 'Diagnostic Test: Stool collection', 'Diagnostic Test: Transit time determination']}], 'interventions': [{'name': 'Oral Polyphenol Challenge Test / PPPIL', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients will receive a so-called oral polyphenol challenge test. It is a pill containing a multitude of polyphenol classes (doi: 10.1093/cdn/nzac072.020)', 'armGroupLabels': ['Non diabetic persons', 'T2DM']}, {'name': 'fasting blood sample', 'type': 'DIAGNOSTIC_TEST', 'description': 'Fasting blood sample will be obtained for determination of markers of metabolic health.', 'armGroupLabels': ['Non diabetic persons', 'T2DM']}, {'name': 'Fasting urine collection', 'type': 'DIAGNOSTIC_TEST', 'description': 'Subjects collect morning urine (or the urine thereafter ) in a separate urine container and write down the time of urine collection for determination of polyphenol metabolites', 'armGroupLabels': ['Non diabetic persons', 'T2DM']}, {'name': '24 hours urine collection', 'type': 'DIAGNOSTIC_TEST', 'description': 'Subjects collect urine over the entire 24h. for determination of polyphenol metabolites', 'armGroupLabels': ['Non diabetic persons', 'T2DM']}, {'name': 'Questionnaires', 'type': 'OTHER', 'description': 'Questionnaires will be performed to collect information on lifestyle and baseline characteristics: physical activity (IPAQ), sleep (PSQI), drinking and smoking behaviour, drug intake and medical record.', 'armGroupLabels': ['Non diabetic persons', 'T2DM']}, {'name': 'Stool collection', 'type': 'DIAGNOSTIC_TEST', 'description': 'Optional: some subjects collect stool samples to test the capacity of the microbiome to degrade polyphenols with a batch experiment.', 'armGroupLabels': ['Non diabetic persons', 'T2DM']}, {'name': 'Transit time determination', 'type': 'DIAGNOSTIC_TEST', 'description': 'Subjects take a pill containing 90mg of royal blue dye (E133) together with the polyphenol pill to determine their transit time. When their stool discolours, the subjects notify the researcher.', 'armGroupLabels': ['Non diabetic persons', 'T2DM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'state': 'East Flanders', 'country': 'Belgium', 'contacts': [{'name': 'Jan Stautemas', 'role': 'CONTACT', 'email': 'jan.stautemas@ugent.be'}], 'facility': 'Ghent University', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'centralContacts': [{'name': 'Jan Stautemas, PhD', 'role': 'CONTACT', 'email': 'jan.stautemas@ugent.be', 'phone': '003293328967'}, {'name': 'Patrick Calders, Professor', 'role': 'CONTACT', 'email': 'patrick.calders@ugent.be'}], 'overallOfficials': [{'name': 'Bruno Lapauw, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'All anonymous data will be made available on request after publication also to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Ghent', 'class': 'OTHER'}, {'name': 'University of Parma', 'class': 'OTHER'}, {'name': 'Universiteit Antwerpen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}