We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Childhood Metabolic Markers of Adult Morbidity in Blacks

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01312051
First Posted: March 10, 2011
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Silva Arslanian, University of Pittsburgh
March 9, 2011
March 10, 2011
October 18, 2017
July 2004
September 20, 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 ]
Same as current
Complete list of historical versions of study NCT01312051 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Childhood Metabolic Markers of Adult Morbidity in Blacks
Childhood Metabolic Markers of Adult Morbidity in Blacks

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.

Not Provided
Observational
Observational Model: Other
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample
Healthy black and white volunteers who are 8 to 17 years of age
  • Healthy
  • Normal Weight
  • Overweight
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
156
September 20, 2011
September 20, 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)
Sexes Eligible for Study: All
8 Years to 17 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01312051
R01HD027503( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Silva Arslanian, University of Pittsburgh
University of Pittsburgh
National Institutes of Health (NIH)
Not Provided
University of Pittsburgh
October 2017