Metabolic and Cardiovascular Impact of CD36 Deficiency in African Americans

Completed

• Conditions: Obesity

• Registration Number: NCT02126735
• Lead Sponsor: Vanderbilt University Medical Center

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-10-14
• Study First Submitted QC: 2014-04-28
• Study First Posted: 2014-04-30
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2016-12-29
• Last Update Posted: 2016-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 %.

Trial Locations

Locations (1)

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States