Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-29 @ 4:33 PM
Study NCT ID:
NCT01250106
Status:
UNKNOWN
Last Update Posted:
2011-07-29
First Post:
2010-11-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotics as a Novel Approach to Modulate Gut Hormone Secretion and Risk Factors of Type 2 Diabetes and Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-03-07', 'releaseDate': '2023-08-04'}, {'resetDate': '2025-02-03', 'releaseDate': '2025-01-09'}], 'estimatedResultsFirstSubmitDate': '2023-08-04'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-07-28', 'studyFirstSubmitDate': '2010-11-24', 'studyFirstSubmitQcDate': '2010-11-29', 'lastUpdatePostDateStruct': {'date': '2011-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin resistance', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'gut hormones (GLP-1, GLP-2, GIP)', 'timeFrame': '8 and 10 weeks'}, {'measure': 'insulin secretion', 'timeFrame': '8 and 10 weeks'}, {'measure': 'measurement of cytokines to define the immune status', 'timeFrame': '8 and 10 weeks', 'description': 'measurement and analysis of proinflammatory cytokines (Interleukin (IL)-6, tumor necrosis factor (TNF)-α, IL-1ß, Macropahge inflammatory protein (MIP)-1ß) and regulatory cytokines (IL-10, transforming growth factor (TGF)-ß, IL1ra) from peripheral blood samples collected during this trial'}, {'measure': 'body weight', 'timeFrame': '8 and 10 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['probiotics', 'prevention', 'dietary intervention', 'insulin resistance', 'obesity', 'type 2 diabetes'], 'conditions': ['Obesity', 'Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '26084343', 'type': 'DERIVED', 'citation': 'Simon MC, Strassburger K, Nowotny B, Kolb H, Nowotny P, Burkart V, Zivehe F, Hwang JH, Stehle P, Pacini G, Hartmann B, Holst JJ, MacKenzie C, Bindels LB, Martinez I, Walter J, Henrich B, Schloot NC, Roden M. Intake of Lactobacillus reuteri improves incretin and insulin secretion in glucose-tolerant humans: a proof of concept. Diabetes Care. 2015 Oct;38(10):1827-34. doi: 10.2337/dc14-2690. Epub 2015 Jun 17.'}]}, 'descriptionModule': {'briefSummary': 'The investigators aim to test the hypothesis that Lactobacillus Reuteri-enriched microbiota improves insulin sensitivity and glucose tolerance in obese healthy and obese type 2 diabetes patients by improving gut hormone secretion and compare these findings to healthy lean subjects.', 'detailedDescription': 'Prediabetes and diabetes are accompanied by insufficient gut hormone release, insulin resistance, insufficient insulin secretory capacity and low grade systemic inflammation. Results of recent animal experiments suggest that ingestion of probiotics not only influences gut microbiota composition and intestinal permeability but also secretion of GLP-2 as well as insulin resistance, components of metabolic syndrome and diabetes development. GLP-2 secretion has been suggested to be a key mediator of probiotic effects mediating decreased intestine permeability through binding to intestinal GLP2 receptor in animal studies. Insulinotropic GLP-1, which is reduced in patients with type 2 diabetes, has also been described to be influenced by gut microbiota composition. We aim to test the hypothesis that Lactobacillus Reuteri-enriched microbiota improves insulin sensitivity and glucose tolerance in obese healthy and obese type 2 diabetes patients by improving gut hormone secretion. In a prospective, double-blinded, placebo controlled randomized 10 weeks trial we aim to investigate metabolic and immunological changes related to modified gut microbiota by analysing (1) gut hormone secretion, (2) insulin sensitivity and glucose tolerance, and (3) systemic LPS concentrations and immune status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obese subjects: age 40 - 65 years, obesity (BMI 30-45 kg/m2), non-smoking, absence of gastrointestinal disease, willingness to abstain from intake of fermented milk products over a study period of 8 weeks.\n* Healthy control subjects: non-obese (BMI 19-25 kg/m2), non-diabetic subjects, matched for age and sex, non-smoking, absence of gastrointestinal disease, willingness to abstain from intake of fermented milk products over a study period of 8 weeks.\n\nExclusion Criteria:\n\n* pregnancy, cancer, chronic diseases, antibiotic therapy, competitive athletes.'}, 'identificationModule': {'nctId': 'NCT01250106', 'briefTitle': 'Probiotics as a Novel Approach to Modulate Gut Hormone Secretion and Risk Factors of Type 2 Diabetes and Complications', 'organization': {'class': 'OTHER', 'fullName': 'German Diabetes Center'}, 'officialTitle': 'Phase I Study of Probiotics as a Novel Approach to Modulate Gut Hormone Secretion and Risk Factors of Type 2 Diabetes and Complications', 'orgStudyIdInfo': {'id': 'Probiotic-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic capsule', 'interventionNames': ['Dietary Supplement: Lactobacillus reuteri']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo capsule', 'interventionNames': ['Dietary Supplement: Lactobacillus reuteri']}], 'interventions': [{'name': 'Lactobacillus reuteri', 'type': 'DIETARY_SUPPLEMENT', 'description': 'twice daily', 'armGroupLabels': ['Probiotic capsule', 'placebo capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40225', 'city': 'Düsseldorf', 'state': 'Duesseldorf', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Nanette C Schloot, MD', 'role': 'CONTACT', 'email': 'schloot@ddz.uni-duesseldorf.de', 'phone': '+49 211 3382', 'phoneExt': '665'}, {'name': 'Marie-Christine Simon, Dipl. Oecotroph', 'role': 'CONTACT', 'email': 'marie-christine.simon@ddz.uni-duesseldorf.de', 'phone': '+49 211 3382', 'phoneExt': '229'}, {'name': 'Nanette C. Schloot, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'German Diabetes Center', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'centralContacts': [{'name': 'Nanette C Schloot, MD', 'role': 'CONTACT', 'email': 'schloot@ddz.uni-duesseldorf.de', 'phone': '+49 211 3382', 'phoneExt': '665'}, {'name': 'Marie-Christine Simon, Dipl. oecotroph.', 'role': 'CONTACT', 'email': 'marie-christine.simon@ddz.uni-duesseldorf.de', 'phone': '+49 211 3382', 'phoneExt': '229'}], 'overallOfficials': [{'name': 'Nanette C Schloot, Priv.-Doz. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'German Diabetes Center, Duesseldorf'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'German Diabetes Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Schloot, Nanette C.', 'oldOrganization': 'German Diabetes Center'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-08-04', 'type': 'RELEASE'}, {'date': '2024-03-07', 'type': 'RESET'}, {'date': '2025-01-09', 'type': 'RELEASE'}, {'date': '2025-02-03', 'type': 'RESET'}], 'unpostedResponsibleParty': 'German Diabetes Center'}}}}