Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT01312051
Status:
COMPLETED
Last Update Posted:
2017-10-18
First Post:
2011-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Childhood Metabolic Markers of Adult Morbidity in Blacks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2011-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-16', 'studyFirstSubmitDate': '2011-03-09', 'studyFirstSubmitQcDate': '2011-03-09', 'lastUpdatePostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skeletal muscle lipid content, insulin sensitivity and insulin secretion', 'timeFrame': 'Assessments at 2 timepoints occur within a 2 to 3 week period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy', 'Normal Weight', 'Overweight']}, 'descriptionModule': {'briefSummary': 'Blacks are at increased risk for obesity, type 2 diabetes mellitus and cardiovascular disease. A common pathogenetic link among these entities is insulin resistance/hyperinsulinemia.\n\nThe specific aims of this project are: 1) to compare skeletal muscle lipid content (SMLC) in black vs white children by computed tomography (CT) scan of the mid-thigh, and assess the relationship to in vivo insulin sensitivity; 2) to test the hypothesis that free fatty acid (FFA) - induced insulin resistance is associated with larger increases in intramyocellular lipid (IMCL) in black vs white adolescents; 3) to examine if β-cell insulin secretion in prepubertal black children is more sensitive to the stimulatory effect of FFA than in whites; and 4) to test if the β-cell in black obese adolescents is more susceptible to the lipotoxic effect of FFA compared with whites. The methods to be used are: the well- established CT method as well as Magnetic Resonance Spectroscopy (1H-MRS) to assess SMLC and IMCL; intralipid infusion to elevate circulating FFA levels; the hyperinsulinemic-euglycemic clamp with stable isotopes and indirect calorimetry to measure insulin sensitivity and substrate turnover; the hyperglycemic clamp to assess insulin secretion; DEXA and whole body MRI for body composition assessments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy black and white volunteers who are 8 to 17 years of age', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nProtocols 1 \\& 4:\n\n* Age 11-17 years\n* Male or Female\n* Healthy\n* Obese, BMI ≥ 95 percentile\n* Pubertal/Tanner Stage II-V\n* African American or White American, based on self identity with no admixture for 3 generations\n\nProtocol 2:\n\n* Age 11-17 years\n* Male or Female\n* Healthy\n* Normal Weight, BMI 10- 95 percentile\n* Pubertal/Tanner Stage II-V\n* African American or White American, based on self-identity with no admixture for 3 generations\n\nProtocol 3:\n\n* Age 8-12 years\n* Male or Female\n* Healthy\n* Normal Weight, BMI 10-95 percentile\n* Prepubertal/Tanner Stage I\n* African American or White American, based on self-identity with no admixture for 3 generations\n\nExclusion Criteria:\n\n* Medications which interfere with metabolism\n* Hemocue \\< 12 gm/dl in pubertal subjects and \\<11gm/dl in prepubertal subjects\n* Positive serum pregnancy test\n* Recent significant weight change or dieting\n* Presence of disease (i.e.diabetes, hypothyroidism, genetic dyslipidemia, etc)'}, 'identificationModule': {'nctId': 'NCT01312051', 'briefTitle': 'Childhood Metabolic Markers of Adult Morbidity in Blacks', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Childhood Metabolic Markers of Adult Morbidity in Blacks', 'orgStudyIdInfo': {'id': 'R01HD027503', 'link': 'https://reporter.nih.gov/quickSearch/R01HD027503', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Protocol 1', 'description': 'Healthy, overweight 11 to 17 year old black and white adolescents'}, {'label': 'Protocol 2', 'description': 'Healthy, normal-weight 11 to 17 year old black and white adolescents'}, {'label': 'Protocol 3', 'description': 'Healthy, normal-weight 8 to 12 year old black and white adolescents'}, {'label': 'Protocol 4', 'description': 'Healthy, overweight 11 to 17 year old black and white adolescents'}]}, 'contactsLocationsModule': {'locations': [{'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Pittsburgh of UPMC", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Silva Arslanian', 'investigatorAffiliation': 'University of Pittsburgh'}}}}