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Childhood Metabolic Markers of Adult Morbidity in Blacks

Sponsor
University of Pittsburgh (Other)
Overall Status
Completed
CT.gov ID
NCT01312051
Collaborator
National Institutes of Health (NIH) (NIH)
156
Enrollment
1
Location
86.6
Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

The 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    156 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Childhood Metabolic Markers of Adult Morbidity in Blacks
    Study Start Date :
    Jul 1, 2004
    Actual Primary Completion Date :
    Sep 20, 2011
    Actual Study Completion Date :
    Sep 20, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    Protocol 1

    Healthy, overweight 11 to 17 year old black and white adolescents
    Protocol 2

    Healthy, normal-weight 11 to 17 year old black and white adolescents
    Protocol 3

    Healthy, normal-weight 8 to 12 year old black and white adolescents
    Protocol 4

    Healthy, overweight 11 to 17 year old black and white adolescents

    Outcome Measures

    Primary Outcome Measures

    1. Skeletal muscle lipid content, insulin sensitivity and insulin secretion [Assessments at 2 timepoints occur within a 2 to 3 week period]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    Protocols 1 & 4:

    • Age 11-17 years

    • Male or Female

    • Healthy

    • Obese, BMI ≥ 95 percentile

    • Pubertal/Tanner Stage II-V

    • African American or White American, based on self identity with no admixture for 3 generations

    Protocol 2:

    • Age 11-17 years

    • Male or Female

    • Healthy

    • Normal Weight, BMI 10- 95 percentile

    • Pubertal/Tanner Stage II-V

    • African American or White American, based on self-identity with no admixture for 3 generations

    Protocol 3:

    • Age 8-12 years

    • Male or Female

    • Healthy

    • Normal Weight, BMI 10-95 percentile

    • Prepubertal/Tanner Stage I

    • African American or White American, based on self-identity with no admixture for 3 generations

    Exclusion Criteria:

    • Medications which interfere with metabolism

    • Hemocue < 12 gm/dl in pubertal subjects and <11gm/dl in prepubertal subjects

    • Positive serum pregnancy test

    • Recent significant weight change or dieting

    • Presence of disease (i.e.diabetes, hypothyroidism, genetic dyslipidemia, etc)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania United States 15224

    Sponsors and Collaborators

    • University of Pittsburgh
    • National Institutes of Health (NIH)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Silva Arslanian, Professor, University of Pittsburgh
    ClinicalTrials.gov Identifier:
    NCT01312051
    Other Study ID Numbers:
    • R01HD027503
    First Posted:
    Mar 10, 2011
    Last Update Posted:
    Oct 18, 2017
    Last Verified:
    Oct 1, 2017
    Additional relevant MeSH terms:
    Overweight

    Study Results

    No Results Posted as of Oct 18, 2017