Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-27 @ 11:11 AM
Study NCT ID:
NCT06007404
Status:
RECRUITING
Last Update Posted:
2025-05-07
First Post:
2023-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
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'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D011236', 'term': 'Prediabetic State'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 175}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-03', 'studyFirstSubmitDate': '2023-06-10', 'studyFirstSubmitQcDate': '2023-08-17', 'lastUpdatePostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucose (OGTT)', 'timeFrame': '120 minutes', 'description': 'Plasma Glucose (mg/dL) will be measured prior to, and throughout, an Oral Glucose Tolerance Test (OGTT). Measurements will be taken at baseline (fasting) and 30, 60, 90 and 120 minutes after consumption of glucose dose'}, {'measure': 'Insulin (OGTT)', 'timeFrame': '120 minutes', 'description': 'Plasma Insulin (µU/mL) will be measured prior to, and throughout, an Oral Glucose Tolerance Test (OGTT). Measurements will be taken at baseline (fasting) and 30, 60, 90 and 120 minutes after consumption of glucose dose'}, {'measure': 'Glucose (MMTT)', 'timeFrame': '180 minutes', 'description': 'Plasma Glucose (mg/dL) will be measured prior to, and throughout, a Mixed Meal Tolerance Test (MMTT). Measurements will be taken at baseline (fasting) and 30, 60, 90, 120 and 180 minutes after consumption of high fat shake.'}, {'measure': 'Insulin (MMTT)', 'timeFrame': '180 minutes', 'description': 'Plasma Insulin (µU/mL) will be measured prior to, and throughout, a Mixed Meal Tolerance Test (MMTT). Measurements will be taken at baseline (fasting) and 30, 60, 90, 120 and 180 minutes after consumption of high fat shake.'}, {'measure': 'Monocyte /macrophage populations by flow cytometry', 'timeFrame': '180 minutes', 'description': 'Frequencies by flow cytometry. Measurements will be taken at baseline sample and 180 minutes after consumption of high fat shake'}], 'secondaryOutcomes': [{'measure': 'Free fatty acids (MMTT)', 'timeFrame': '180 minutes', 'description': 'Serum Free fatty acids (mmol/L) will be measured prior to, and throughout, a Mixed Meal Tolerance Test (MMTT). Measurements will be taken at baseline (fasting) and 30, 60, 90, 120 and 180 minutes after consumption of high fat shake'}, {'measure': 'Triglycerides (MMTT)', 'timeFrame': '180 minutes', 'description': 'Serum Triglycerides (mg/dL) will be measured prior to, and throughout, a Mixed Meal Tolerance Test (MMTT). Measurements will be taken at baseline (fasting) and 30, 60, 90, 120 and 180 minutes after consumption of high fat shake'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes', 'Insulin Resistance', 'Obesity', 'Metabolic Disease', 'PreDiabetes']}, 'descriptionModule': {'briefSummary': 'This research study collects health-related information and blood samples to better understand how body composition, lifestyle habits, and diet influence meta-inflammatory monocytes (MiMos) in adolescents. The hypothesis of this study is that adolescents at risk for metabolic disease have enhanced MiMo related activities leading to insulin resistance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants may be recruited from a variety of sites including University of Michigan clinical sites, non-University of Michigan clinical sites, local communities and schools throughout Southeast Michigan, and the University of Michigan campus.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 14 and 18 years of age\n* Tanner stage 4 or 5 (mature adult stage of puberty)\n* Normal weight (BMI ≥ 5th percentile \\& \\< 85th percentile), overweight (BMI \\> 86th percentile) \\& \\< 94th percentile), obese weight (BMI percentile ≥ 95th percentile), and/or pre-diabetes (HbA1c \\> 5.7%)\n* For Type 2 Diabetes cohort, diagnosis of Type 2 Diabetes\n\nExclusion Criteria:\n\n* Currently pregnant\n* Use medications known to affect glucose metabolism (immunosuppressive medications, cancer medications, or high dose steroids), unless prescribed for Type 2 Diabetes management\n* Prior diagnosis of autoimmune disease, cancer, or a cognitive or perceptual disability that would inhibit following directions of study staff\n* Allergies or intolerance to milk, soy, or palm oil'}, 'identificationModule': {'nctId': 'NCT06007404', 'briefTitle': 'Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'The Role of Circulating Meta-Inflammatory Monocytes in Adolescent Insulin Resistance', 'orgStudyIdInfo': {'id': 'HUM00208301'}, 'secondaryIdInfos': [{'id': 'R01DK130864', 'link': 'https://reporter.nih.gov/quickSearch/R01DK130864', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal weight', 'description': 'BMI ≥ 5th percentile \\& \\< 85th percentile'}, {'label': 'Obese weight', 'description': 'BMI ≥ 95th percentile'}, {'label': 'PreDiabetes', 'description': 'HbA1c \\> 5.7%'}, {'label': 'Type 2 Diabetes', 'description': 'Diagnosed with Type 2 Diabetes'}, {'label': 'Overweight', 'description': 'BMI \\> 86th percentile and \\<94th percentile'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'centralContacts': [{'name': 'The Singer Lab Team', 'role': 'CONTACT', 'email': 'MiMoStudy@med.umich.edu', 'phone': '(734) 615-4938'}], 'overallOfficials': [{'name': 'Kanakadurga Singer, MA, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Genotype/sequencing and phenotype data will be submitted after the genotyping/sequencing data have been cleaned. Following submission, data will be released within six months.', 'ipdSharing': 'YES', 'description': 'Genomic and associated phenotypic data will be shared through NIH-designated data repositories.', 'accessCriteria': 'In regards to genomic data, individual-level data will be deidentified and made available through controlled-access.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Kanakadurga Singer', 'investigatorAffiliation': 'University of Michigan'}}}}