Metabolic and Cardiovascular Impact of CD36 Deficiency in African Americans

NCT02126735 | Completed

• 1 other identifier: 121525
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Area Under the Concentration-Time Curve triglycerides levels after high fat meal

  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

  Baseline values prior to high fat meal and at 10, 20, 30, 60, 120, 240 & 360 minutes

Secondary Outcomes (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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

we will recruit subjects locally

You may qualify if:

• African American men and women age 18-65 years of age
• BMI 25-45 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Related Publications (2)

• 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.

  PMID: 29546316 DERIVED

• 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.

  PMID: 26541392 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

serum, white cells

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cyndya A Shibao, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: October 14, 2013
• First Posted: April 30, 2014
• Study Start: August 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 30, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)