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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
  Purpose

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
Healthy Normal Weight Overweight

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Childhood Metabolic Markers of Adult Morbidity in Blacks

Resource links provided by NLM:


Further study details as provided by Silva Arslanian, University of Pittsburgh:

Primary Outcome Measures:
  • Skeletal muscle lipid content, insulin sensitivity and insulin secretion [ Time Frame: Assessments at 2 timepoints occur within a 2 to 3 week period ]

Enrollment: 156
Study Start Date: July 2004
Study Completion Date: September 20, 2011
Primary Completion Date: September 20, 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy black and white volunteers who are 8 to 17 years of age
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01312051


Locations
United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Sponsors and Collaborators
University of Pittsburgh
National Institutes of Health (NIH)
  More Information

Responsible Party: Silva Arslanian, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01312051     History of Changes
Other Study ID Numbers: R01HD027503 ( U.S. NIH Grant/Contract )
First Submitted: March 9, 2011
First Posted: March 10, 2011
Last Update Posted: October 18, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms