Childhood Metabolic Markers of Adult Morbidity in Blacks

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Children's Hospital of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Children's Hospital of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01312051
First received: March 9, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted

March 9, 2011
March 9, 2011
July 2004
September 2011   (final data collection date for primary outcome measure)
Skeletal muscle lipid content, insulin sensitivity and insulin secretion [ Time Frame: Assessments at 2 timepoints occur within a 2 to 3 week period ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
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Childhood Metabolic Markers of Adult Morbidity in Blacks
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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.

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Observational
Time Perspective: Cross-Sectional
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Non-Probability Sample

Healthy black and white volunteers who are 8 to 17 years of age

  • Healthy
  • Normal Weight
  • Overweight
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  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
September 2011
September 2011   (final data collection date for primary outcome measure)

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)
Both
8 Years to 17 Years
Yes
Contact: Jacqueline Washington, BS 412-692-5201 jacqueline.washington@chp.edu
Contact: Nancy Guerra, CRNP 412-692-8405 nancy.guerra@chp.edu
United States
 
NCT01312051
R01HD027503
No
Silva Arslanian, MD, Children's Hospital of Pittsburgh of UPMC, University of Pittsburgh
Children's Hospital of Pittsburgh
National Institutes of Health (NIH)
Not Provided
Children's Hospital of Pittsburgh
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP