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.

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Key information

Conditions

Healthy Body Weight Normal Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

Skeletal muscle lipid content, insulin sensitivity and insulin secretion

Time frame: Assessments at 2 timepoints occur within a 2 to 3 week period

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

National Institutes of Health (NIH)

Registry information

Important dates

Study start: 2004
Primary completion: 2011
Study completion: 2011
First posted: Mar 10, 2011
Registry last updated: Oct 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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