Clinical trial NCT02126735: Metabolic and Cardiovascular Impact of CD36 Deficiency in African Americans
Official title: Metabolic and Cardiovascular Impact of CD36 Deficiency in African Americans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2014-04-30
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: we will recruit subjects locally

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


Eligibility criteria: 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

Primary outcomes:
measure: Area Under the Concentration-Time Curve triglycerides levels after high fat meal
timeFrame: Baseline values prior to high fat meal and at 10, 20, 30, 60, 120, 240 & 360 minutes
Secondary outcomes:
measure: percent change in flow mediated dilation at baseline and 4 hours after a high fat meal
timeFrame: Change from baseline in flow mediated dilation at 4 hours after high fal meal
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Cyndya A Shibao, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shibao CA, Celedonio JE, Tamboli R, Sidani R, Love-Gregory L, Pietka T, Xiong Y, Wei Y, Abumrad NN, Abumrad NA, Flynn CR. CD36 Modulates Fasting and Preabsorptive Hormone and Bile Acid Levels. J Clin Endocrinol Metab. 2018 May 1;103(5):1856-1866. doi: 10.1210/jc.2017-01982.
citation: Marinos A, Celedonio JE, Ramirez CE, Gottlieb J, Gamboa A, Hui N, Yu C, Stein CM, Biaggioni I, Shibao CA. Time-Course Analysis of Flow Mediated Dilation for the Evaluation of Endothelial Function After a High-Fat Meal in African Americans. J Am Heart Assoc. 2015 Nov 5;4(11):e002388. doi: 10.1161/JAHA.115.002388.