Clinical trial NCT01312051: Childhood Metabolic Markers of Adult Morbidity in Blacks
Official title: Childhood Metabolic Markers of Adult Morbidity in Blacks
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Normal Weight
Overweight
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2011-03-10
Enrollment: 156
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy black and white volunteers who are 8 to 17 years of age

Brief 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.


Eligibility 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)

Primary outcomes:
measure: Skeletal muscle lipid content, insulin sensitivity and insulin secretion
timeFrame: Assessments at 2 timepoints occur within a 2 to 3 week period
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
Study officials:
References: