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
  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: Time Perspective: Cross-Sectional

Resource links provided by NLM:


Further study details as provided by Children's Hospital 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2004
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 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

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01312051

Contacts
Contact: Jacqueline Washington, BS 412-692-5201 jacqueline.washington@chp.edu
Contact: Nancy Guerra, CRNP 412-692-8405 nancy.guerra@chp.edu

Locations
United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Principal Investigator: Silva Arslanian, MD         
Sponsors and Collaborators
Children's Hospital of Pittsburgh
  More Information

No publications provided

Responsible Party: Silva Arslanian, MD, Children's Hospital of Pittsburgh of UPMC, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01312051     History of Changes
Other Study ID Numbers: R01HD027503
Study First Received: March 9, 2011
Last Updated: March 9, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 02, 2014