Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-28 @ 1:12 AM
Study NCT ID:
NCT06525259
Status:
RECRUITING
Last Update Posted:
2025-05-09
First Post:
2024-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DISCOVERY of Risk Factors for Type 2 Diabetes in Youth
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-07', 'studyFirstSubmitDate': '2024-07-18', 'studyFirstSubmitQcDate': '2024-07-24', 'lastUpdatePostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Type 2 diabetes', 'timeFrame': 'Through study completion, an average of 2.5 years', 'description': 'Development of type 2 diabetes, as defined by a hemoglobin A1c (HbA1c) ≥6.5% at an annual or mid-year visit followed by a confirmatory HbA1c ≥6.5% collected within 2 weeks of the first value.'}], 'secondaryOutcomes': [{'measure': 'Glycemia, β-cell function, insulin sensitivity, and free fatty acid flux', 'timeFrame': 'Through study completion, an average of 2.5 years', 'description': 'Intermediary changes in glycemia, β-cell function, insulin sensitivity, and free fatty acid flux along the spectrum of normal glycemia to prediabetes to type 2 diabetes.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus Type 2, Childhood-Onset']}, 'descriptionModule': {'briefSummary': 'The goal of the DISCOVERY study is to provide innovative critical information regarding the unique natural history of glycemic control, insulin sensitivity, and β-cell function, and their mechanistic determinates, in obese adolescents at risk for developing type 2 diabetes.', 'detailedDescription': 'The DISCOVERY study will extensively phenotype a large cohort of youth at-risk for type 2 diabetes, as they transition through puberty, and characterize the course of dysfunction in pathophysiological indicators that lead to type 2 diabetes. The knowledge gained from this study of the pathophysiology and epidemiology of youth-onset type 2 diabetes with deep biochemical, clinical, and psychosocial phenotyping will critically inform the design and testing of future treatment and prevention approaches.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '9 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '3,600 youth, aged 9-14 years at enrollment, of all genders and race/ethnic groups from 15 clinical centers in the United States will be included. Youth will be overweight or obese (BMI ≥85th percentile for age) and have evidence of dysglycemia with an HbA1c range from 5.5-6.4% at screening.', 'eligibilityCriteria': 'Inclusion Criteria:\n\nScreening will occur to enrich the yield of individuals who are highly predisposed to develop youth-onset type 2 diabetes and include those with all of the criteria in Category A:\n\n* Overweight or obesity with BMI ≥85th percentile\n* Age 9-13 year for girls, 10-14 year for boys (inclusion younger for girls as puberty tends to start a year earlier in girls)\n* Tanner Stage 2, 3, or 4\n* Elevated HbA1c 5.5-6.4%\n\nParticipants who meet all of these categories will further need to meet at least one criterion in Category B:\n\n* Family history of type 2 diabetes in 1st or 2nd degree relative\n* Personal exposure to maternal diabetes (i.e., gestational diabetes mellitus (GDM) or mother with type 1 or type 2 diabetes while pregnant with participant)\n* HbA1c ≥6.0%\n* Severe obesity (BMI ≥99th percentile)\n* Personal history of intrauterine growth restriction (IUGR), small for gestational age (SGA), or low birth weight\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation:\n\n* Diabetes based on history, or HbA1c ≥6.5% in the medical record or at screening\n* Unable/unwilling to provide consent/participate fully\n* Conditions predisposing to diabetes or altering the trajectory of puberty (transplant, cancer, Down Syndrome, Turner Syndrome, Klinefelter Syndrome, ovarian/testicular failure, etc.)\n* Medications affecting glucose dynamics during the screening and enrollment period (oral steroids, inhaled steroids \\>1,000mcg/day past month, atypical antipsychotics, topiramate)\n* Prior treatment with insulin\n* Use of glucagon-like peptide-1 (GLP-1) receptor agonist or any weight loss medications in the 6 weeks prior to enrollment\n* Planning treatment with glucagon-like peptide-1 (GLP-1) receptor agonist or any weight loss medications\n* Use of metformin or any glucose lowering medication for a reason other than treatment of diabetes (e.g., for PCOS) in the 6 weeks prior to enrollment\n* Known syndromic/monogenic obesity\n* Blood disorders impacting HbA1c (e.g., anemia, hemoglobin variants)\n* Major systemic organ disease\n* History of bariatric surgery or currently planning bariatric surgery\n* Current pregnancy or currently planning pregnancy\n* Use of GnRH agonist, estrogen, or testosterone\n* Individuals who do not speak English or Spanish, given validation of the questionnaires to be utilized'}, 'identificationModule': {'nctId': 'NCT06525259', 'acronym': 'DISCOVERY', 'briefTitle': 'DISCOVERY of Risk Factors for Type 2 Diabetes in Youth', 'organization': {'class': 'OTHER', 'fullName': 'George Washington University'}, 'officialTitle': 'DISCOVERY of Risk Factors for Type 2 Diabetes in Youth', 'orgStudyIdInfo': {'id': 'U01DK134971', 'link': 'https://reporter.nih.gov/quickSearch/U01DK134971', 'type': 'NIH'}}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Adrienna Stephens', 'role': 'CONTACT', 'email': 'discovery@uab.edu', 'phone': '205-975-6579'}, {'name': 'Barbara Gower, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ambika Ashraf, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85004', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Irene Marquez', 'role': 'CONTACT', 'email': 'imarqu13@asu.edu', 'phone': '602-496-0147'}, {'name': 'Gabriel Shaibi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Arizona State University', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lynette B Davis', 'role': 'CONTACT', 'email': 'Ldavis8@phoenixchildrens.com', 'phone': '602-933-6359'}, {'name': 'Melissa Chambers, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Phoenix Children's", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Leticia Eufracio', 'role': 'CONTACT', 'email': 'leufracio@chla.usc.edu', 'phone': '323-497-5088'}, {'name': 'Michael Goran, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kelly Wiitala', 'role': 'CONTACT', 'email': 'DISCOVERY@childrenscolorado.org', 'phone': '720-777-2855'}, {'name': 'Kristen Nadeau, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Megan Kelsey, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33701', 'city': 'St. Petersburg', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Antonika Ford', 'role': 'CONTACT', 'email': 'aford38@jh.edu', 'phone': '727-898-4895'}, {'name': 'Sheela N Magge, MD, MSCE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Johns Hopkins All Children's Hospital", 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Benjamin Potts', 'role': 'CONTACT', 'email': 'bpotts2@jh.edu', 'phone': '443-287-8997'}, {'name': 'Hannah Hardeo', 'role': 'CONTACT', 'email': 'hhardeo1@jhu.edu'}, {'name': 'Sheela N Magge, MD, MSCE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Johns Hopkins University School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jackson Tu', 'role': 'CONTACT', 'email': 'DISCOVERYTeam@joslin.harvard.edu', 'phone': '617-309-4193'}, {'name': 'Elvira Isganaitis, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Amy Fleischman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Takara Stanley, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Boston Children's/Joslin Diabetes Center/Massachusetts General Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '87420', 'city': 'Shiprock', 'state': 'New Mexico', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Melanie Aspaas', 'role': 'CONTACT', 'email': 'melanie.aspaas@cuanschutz.edu', 'phone': '720-957-5074'}, {'name': 'Dana Dabelea, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Wei Perng, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Colorado Navajo Nation', 'geoPoint': {'lat': 36.78555, 'lon': -108.68703}}, {'zip': '11220', 'city': 'Brooklyn', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Celia Engelson', 'role': 'CONTACT', 'email': 'DiscoveryStudyBrooklyn@nyulangone.org', 'phone': '929-731-2272'}, {'name': 'Mary Pat Gallagher, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Alan Jacobson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NYU Langone Health- Brooklyn', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '11530', 'city': 'Garden City', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marilyn Richardson', 'role': 'CONTACT', 'email': 'DiscoveryStudyLI@nyulangone.org', 'phone': '516-969-6120'}, {'name': 'Alan Jacobson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NYU Langone Health- Long Island', 'geoPoint': {'lat': 40.72677, 'lon': -73.6343}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Laura March', 'role': 'CONTACT', 'email': 'DiscoveryStudyManhattan@nyulangone.org', 'phone': '929-731-2272'}, {'name': 'Mary Pat Gallagher, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NYU Langone Health- Manhattan', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nicole Maysonet', 'role': 'CONTACT', 'email': 'einstein-discoverystudy@einsteinmed.edu', 'phone': '347-949-3964'}, {'name': 'Carmen R Isasi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Albert Einstein College of Medicine', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Merischia Griffin', 'role': 'CONTACT', 'email': 'pediatricresearch@atriumhealth.org', 'phone': '704-446-4804'}, {'name': 'Christine Turley, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Atrium Health', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alisha Davis', 'role': 'CONTACT', 'email': 'Discovery_Study@wakehealth.edu', 'phone': '336-713-3132'}, {'name': 'Elizabeth Jensen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wake Forest University', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hailey Eisenmann', 'role': 'CONTACT', 'email': 'discoveryinteens@cchmc.org', 'phone': '513-803-6708'}, {'name': 'Allen Riegler', 'role': 'CONTACT', 'email': 'Allen.Riegler@cchmc.org'}, {'name': 'Amy S Shah, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Cincinnati Children's Hospital", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jacqueline Brito', 'role': 'CONTACT', 'email': 'Jacqueline.brito@nationwidechildrens.org', 'phone': '614-722-8528'}, {'name': 'Robert P Hoffman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ihuoma Eneli, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeff Preske', 'role': 'CONTACT', 'email': 'discoverystudy@ou.edu', 'phone': '405-271-7554'}, {'name': 'Jeanie B Tryggestad, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University of Oklahoma Health Sciences Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sarah Loughran', 'role': 'CONTACT', 'email': 'DISCOVERYSTUDY@CHOP.EDU', 'phone': '215-590-2134'}, {'name': 'Beth Schwartzman', 'role': 'CONTACT', 'email': 'schwartzmann@chop.edu'}, {'name': 'Lorraine E Levitt Katz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jesus Cazares', 'role': 'CONTACT', 'email': 'jesus.cazares@bcm.edu', 'phone': '713-798-7132'}, {'name': 'Dahlia Solorzano', 'role': 'CONTACT', 'email': 'dahlia.solorzano@bcm.edu', 'phone': '713-798-7125'}, {'name': 'Fida Bacha, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Baylor College of Medicine / Texas Children's", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Barbara Braffett, PhD', 'role': 'CONTACT', 'email': 'braffett@bsc.gwu.edu', 'phone': '3018819260'}, {'name': 'Brian Burke, MS', 'role': 'CONTACT', 'email': 'bburke@bsc.gwu.edu', 'phone': '3018819260'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'George Washington University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Barbara Braffett', 'investigatorAffiliation': 'George Washington University'}}}}