Expired Study
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Pittsburgh, Pennsylvania 15224


Purpose:

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.


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)


Study is Available At:


Original ID:

R01HD027503


NCT ID:

NCT01312051


Secondary ID:


Study Acronym:


Brief Title:

Childhood Metabolic Markers of Adult Morbidity in Blacks


Official Title:

Childhood Metabolic Markers of Adult Morbidity in Blacks


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

8 Years


Maximum Age:

17 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Pittsburgh


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

4


Total Enrollment:

156


Enrollment Type:

Actual


Study Dates

Start Date:July 2004
Completion Date:September 20, 2011
Completion Type:Actual
Primary Completion Date:September 20, 2011
Primary Completion Type:Actual
Verification Date:October 2017
Last Changed Date:October 16, 2017
First Received Date:March 9, 2011

Study Outcomes

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

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:Protocol 1
Description:Healthy, overweight 11 to 17 year old black and white adolescents
Study Arm Type:Other
Arm Name:Protocol 2
Description:Healthy, normal-weight 11 to 17 year old black and white adolescents
Study Arm Type:Other
Arm Name:Protocol 3
Description:Healthy, normal-weight 8 to 12 year old black and white adolescents
Study Arm Type:Other
Arm Name:Protocol 4
Description:Healthy, overweight 11 to 17 year old black and white adolescents

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Pittsburgh
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institutes of Health (NIH)

Samples and Retentions

Study Population: Healthy black and white volunteers who are 8 to 17 years of age
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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