Ignite Creation Date:
2025-12-26 @ 5:22 PM
Ignite Modification Date:
2026-01-22 @ 8:43 AM
Study NCT ID:
NCT02938806
Status:
COMPLETED
Last Update Posted:
2022-05-31
First Post:
2016-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Type 1 Diabetes Mellitus and Increased Weight on Gut Microbiome and Urine Metabolome Profiles in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Stool Urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-26', 'studyFirstSubmitDate': '2016-10-17', 'studyFirstSubmitQcDate': '2016-10-17', 'lastUpdatePostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of gut microbial composition and diversity by 16S rRNA sequencing', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Analysis of urine metabolite concentrations measured by mass spectrometry', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity', 'Overweight', 'Type 1 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '22211896', 'type': 'BACKGROUND', 'citation': 'Boerner BP, Sarvetnick NE. Type 1 diabetes: role of intestinal microbiome in humans and mice. Ann N Y Acad Sci. 2011 Dec;1243:103-18. doi: 10.1111/j.1749-6632.2011.06340.x.'}, {'pmid': '24628412', 'type': 'BACKGROUND', 'citation': 'Dunne JL, Triplett EW, Gevers D, Xavier R, Insel R, Danska J, Atkinson MA. The intestinal microbiome in type 1 diabetes. Clin Exp Immunol. 2014 Jul;177(1):30-7. doi: 10.1111/cei.12321.'}, {'pmid': '26615014', 'type': 'BACKGROUND', 'citation': 'Zimny D, Szatkowska M, Polubok J, Maciaszek J, Machaj M, Barg E. [The use of metabolomics in medicine - some examples of oncological and metabolic diseases]. Pediatr Endocrinol Diabetes Metab. 2015;20(2):55-62. doi: 10.18544/PEDM-20.02.0003. Polish.'}]}, 'descriptionModule': {'briefSummary': 'This study employs a cross-sectional design to profile the gut microbiome and urine metabolome in overweight/obese children with type 1 diabetes (T1D).', 'detailedDescription': 'The investigators will obtain stool and urine samples from subjects aged 7-17 years in 4 groups:\n\n* Group 1: Obese or overweight children within 3 years of diagnosis of T1D\n* Group 2: Normal weight children within 3 years of diagnosis of T1D\n* Group 3: Obese or overweight children without T1D\n* Group 4: Normal weight children without T1D\n\nType 1 diabetes will be defined according to American Diabetes Association criteria along with the presence of pancreatic autoantibodies (GAD65, ICA512, or insulin autoantibodies). Obese and overweight status will be defined by BMI \\>85th percentile for age and gender according to CDC criteria.\n\nAll subjects will provide one-time stool and first morning urine sample. Overweight or obese subjects will additionally have a point of care blood glucose and hemoglobin A1c measurement to ensure that they do not have diabetes.\n\nThe investigators will perform 16S rRNA sequencing of stool bacteria and mass spectrometry measurement of urine metabolites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '7 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children aged 7-17 years with/without T1DM and with/without obese/overweight status in San Diego, California', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 7 to 17 years\n* Diagnosis of diabetes will be defined by current American Diabetes Association criteria ° (fasting glucose \\> 126 mg/dl, 2 hour OGTT glucose \\> 200 mg/dl; random glucose \\> 200 with symptoms of hyperglycemia; or HbA1c \\> 6.5%)\n* Diabetes duration \\< 3 years\n* Presence of pancreatic autoimmunity (GAD65, ICA512, or insulin autoantibody positivity)\n* Adult caregiver willing to actively support study participation\n* Signed parental informed consent form and minor child informed assent form\n\nExclusion Criteria:\n\n* Other significant organ system illness or condition (including psychiatric or developmental disorder) that, in the opinion of the investigator, would prevent participation'}, 'identificationModule': {'nctId': 'NCT02938806', 'briefTitle': 'The Effects of Type 1 Diabetes Mellitus and Increased Weight on Gut Microbiome and Urine Metabolome Profiles in Children', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'The Effects of Type 1 Diabetes Mellitus and Increased Weight on Gut Microbiome and Urine Metabolome Profiles in Children', 'orgStudyIdInfo': {'id': '#160113'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obese/overweight children with T1D', 'description': 'No intervention', 'interventionNames': ['Other: No intervention']}, {'label': 'Normal weight children with T1D', 'description': 'No intervention', 'interventionNames': ['Other: No intervention']}, {'label': 'Obese/overweight children, no diabetes', 'description': 'No intervention', 'interventionNames': ['Other: No intervention']}, {'label': 'Healthy, normal weight children', 'description': 'No intervention', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Healthy, normal weight children', 'Normal weight children with T1D', 'Obese/overweight children with T1D', 'Obese/overweight children, no diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Rady Children's Hospital Endocrinology Department", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Jane Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dr Jane Kim', 'investigatorAffiliation': 'University of California, San Diego'}}}}