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Childhood Metabolic Markers of Adult Morbidity in Blacks

University of Pittsburgh logo

University of Pittsburgh

Status

Completed

Conditions

Overweight
Healthy
Normal Weight

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT01312051
R01HD027503

Details and patient eligibility

About

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.

Enrollment

156 patients

Sex

All

Ages

8 to 17 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

156 participants in 4 patient groups

Protocol 1
Description:
Healthy, overweight 11 to 17 year old black and white adolescents
Protocol 2
Description:
Healthy, normal-weight 11 to 17 year old black and white adolescents
Protocol 3
Description:
Healthy, normal-weight 8 to 12 year old black and white adolescents
Protocol 4
Description:
Healthy, overweight 11 to 17 year old black and white adolescents

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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