Obesity
Conditions
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
Interventions
None listed
Sponsors
Vanderbilt University Medical Center
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 %. |
Countries
United States
Outcome results
None listed