ObesityNCT02126735
Metabolic and Cardiovascular Impact of CD36 Deficiency in African Americans
An observational study of Obesity, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: we will recruit subjects locally
Who may be able to join
- African American men and women age 18-65 years of age
- BMI 25-45 kg/m2
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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 %.
Measured: Change from baseline in flow mediated dilation at 4 hours after high fal meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startAug 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cyndya Shibao, Vanderbilt University Medical Center
- Investigators
- Cyndya A Shibao, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126735
- Sponsor's protocol ID
- 121525
- Status last verified
- Dec 2016
- First submitted
- 14 Oct 2013
- Last updated
- 30 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29546316Marinos 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.
PubMed 26541392
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic and Cardiovascular Impact of CD36 Deficiency in African Americans
- ClinicalTrials.gov ID
- NCT02126735
- Acronym / sponsor ID
- 121525
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- we will recruit subjects locally
Key inclusion criteria (2 listed)
- African American men and women age 18-65 years of age
- BMI 25-45 kg/m2
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Area Under the Concentration-Time Curve triglycerides levels after high fat meal
Time frame: 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
1 secondary outcome
percent change in flow mediated dilation at baseline and 4 hours after a high fat meal
Time frame: Change from baseline in flow mediated dilation at 4 hours after high fal meal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2016.
- Derived from this study: PubMed 29546316Shibao 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.
- Derived from this study: PubMed 26541392Marinos 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cyndya A Shibao, MD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Concentration-Time Curve triglycerides levels after high fat meal (time frame: Baseline values prior to high fat meal and at 10, 20, 30, 60, 120, 240 & 360 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02126735, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2016.