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Metabolic and Cardiovascular Impact of CD36 Deficiency in African Americans

Sponsor
Vanderbilt University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02126735
Collaborator
(none)
21
Enrollment
1
Location
40
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

CD36, a protein that facilitates tissue uptake of fat, as a common link between blood fat concentrations and metabolic disease states such as diabetes mellitus. Genetic variants in the CD36 gene are more common in African Americans compared to Whites and it may confer protection against metabolic diseases by altering the amount of fat in the blood.

The purpose of this study is to compare the levels of fat in the blood and to assess endothelial dysfunction among carriers versus non-carriers of the coding SNP, rs3211938 of the CD36 gene after a high fat meal challenge

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    21 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Metabolic and Cardiovascular Impact of CD36 Deficiency in African Americans
    Study Start Date :
    Aug 1, 2013
    Actual Primary Completion Date :
    Dec 1, 2016
    Actual Study Completion Date :
    Dec 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Area Under the Concentration-Time Curve triglycerides levels after high fat meal [Baseline values prior to high fat meal and at 10, 20, 30, 60, 120, 240 & 360 minutes]

      We expect that subjects heterozygous for the minor allele of CD36 rs3211938 (G/T) would have an increase of 250 units in the area under the curve for triglycerides which is ~50% of the observed difference between patients with CD36 deficiency and normal controls. Assuming that the common standard deviation is 199, using a two group t-test with a type I error of 0.05, a total of 28 subjects (14 carriers and 14 non-carriers) would provide 90% power to detect a difference in our primary endpoint between carriers versus non-carriers of genotype

    Secondary Outcome Measures

    1. percent change in flow mediated dilation at baseline and 4 hours after a high fat meal [Change from baseline in flow mediated dilation at 4 hours after high fal meal]

      our primary outcome will be the percent change in flow mediated dilation at baseline and 4 hours after a high fat meal (peak effect). Assuming a conservative estimate of standard deviation of 3.19 our proposed study with a total of 28 subjects (14 carriers and 14 non-carriers) would have at least 80% power with type I error of 0.05 to detect a minimum difference in the mean response of 3.5 %.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • African American men and women age 18-65 years of age

    • BMI 25-45 kg/m2

    Exclusion Criteria:

    • Diabetes

    • Pregnancy

    • Use of nicotinic acid for dyslipidemia

    • History of nutrient malabsorption

    • Clinically significant hepatic or renal disease, OR serum creatinine or liver function tests > 2times upper limits of normal

    • Symptomatic acute or chronic gallbladder disease

    • Any underlying or acute disease requiring regular medication which could in the principal investigator's opinion possibly pose a threat to the subject or make implementation of the protocol difficult

    • Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study

    • Patient unwilling or unable to give informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vanderbilt University Nashville Tennessee United States 37232

    Sponsors and Collaborators

    • Vanderbilt University Medical Center

    Investigators

    • Principal Investigator: Cyndya A Shibao, MD, Vanderbilt University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cyndya Shibao, Assistant Professor of Medicine, Vanderbilt University Medical Center
    ClinicalTrials.gov Identifier:
    NCT02126735
    Other Study ID Numbers:
    • 121525
    First Posted:
    Apr 30, 2014
    Last Update Posted:
    Dec 30, 2016
    Last Verified:
    Dec 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No

    Study Results

    No Results Posted as of Dec 30, 2016