Childhood Metabolic Markers of Adult Morbidity in Blacks

Healthy Clinical Trial

Official title:

Childhood Metabolic Markers of Adult Morbidity in Blacks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01312051
• Other study ID #: R01HD027503
• Status: Completed
• Phase: N/A
• First received: March 9, 2011
• Last updated: October 16, 2017
• Start date: July 2004
• Est. completion date: September 20, 2011

Study information

• Verified date: October 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: September 20, 2011
• Est. primary completion date: September 20, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy
• Normal Weight
• Overweight

Locations

Country	Name	City	State
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skeletal muscle lipid content, insulin sensitivity and insulin secretion		Assessments at 2 timepoints occur within a 2 to 3 week period