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Childhood Metabolic Markers of Adult Morbidity in Blacks

Childhood Metabolic Markers of Adult Morbidity in Blacks

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01312051
Enrollment
156
Registered
2011-03-10
Start date
2004-07-31
Completion date
2011-09-20
Last updated
2017-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Normal Weight, Overweight

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.

Interventions

None listed

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
University of Pittsburgh
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
8 Years to 17 Years
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)

Design outcomes

Primary

MeasureTime frame
Skeletal muscle lipid content, insulin sensitivity and insulin secretionAssessments at 2 timepoints occur within a 2 to 3 week period

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026