Childhood Metabolic Markers of Adult Morbidity in Blacks

October 16, 2017 updated by: Silva Arslanian, University of Pittsburgh

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15224
    - Children's Hospital of Pittsburgh of UPMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 17 years (Child)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Other
Time Perspectives: Cross-Sectional

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Skeletal muscle lipid content, insulin sensitivity and insulin secretion Time Frame: Assessments at 2 timepoints occur within a 2 to 3 week period	Assessments at 2 timepoints occur within a 2 to 3 week period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

September 20, 2011

Study Completion (Actual)

September 20, 2011

Study Registration Dates

First Submitted

March 9, 2011

First Submitted That Met QC Criteria