Childhood Metabolic Markers of Adult Morbidity in Blacks

NCT01312051 | Completed

• 1 other identifier: R01HD027503
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Normal Weight; Overweight

Outcome Measures

Primary Outcomes (1)

• Skeletal muscle lipid content, insulin sensitivity and insulin secretion

  Assessments at 2 timepoints occur within a 2 to 3 week period

Study Arms (4)

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 Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Healthy black and white volunteers who are 8 to 17 years of age

You may qualify if:

• 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:

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 9, 2011
• First Posted: March 10, 2011
• Study Start: July 1, 2004
• Primary Completion: September 20, 2011
• Study Completion: September 20, 2011
• Last Updated: October 18, 2017

Record last verified: 2017-10

Locations

US (1)