Vascular Function, Insulin Sensitivity, and Vitamin D

NCT ID: NCT01041547

Last Updated: 2014-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2013-12-31

Brief Summary

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The overall objectives of this study are to examine the relationships between circulating vitamin D, insulin sensitivity, and multiple indices of vascular function and to examine whether vitamin D deficiency in African Americans (AA) and White Hispanics (WH) is responsible for ethnic differences in insulin sensitivity and hypertension in AA, WH and European Americans (EA), as well as mechanisms underlying the association between insulin resistance and blood pressure. We hypothesize that 1) serum 25(OH)D is associated with insulin sensitivity and vascular functioning, independent of adiposity, 2) lower insulin sensitivity and vascular functioning in AA and WH relative to EA is due to lower circulating 25(OH)D in AA, and 3) the relationship between insulin resistance and vascular dysfunction is mediated by 25(OH)D.

Acronyms: African American (AA), European American (EA), White Hispanics (WH), Serum 25-hydroxy vitamin D (25()H)D, Body mass index (BMI), Alabama (AL).

Detailed Description

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Conditions

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Insulin Sensitivity Flow-mediated Dilation Arterial Stiffness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy adults

healthy adults with BMI below 32, between ages 19-60 yrs, both males and females

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* African American (AA), White Hispanic (WH), and European American (EA) race
* Ages 19-60 years
* Negative urine pregnancy test
* No evidence of diabetes
* Not on medications that can affect vascular functioning or insulin sensitivity

Exclusion Criteria

* BMI \> 32 kg/m2
* Diabetes or any chronic diseases
* Use of medication(s) known to influence body composition, vascular function, or glucose metabolism
* Regular smoking
* Regular use of illegal drugs and pregnancy
Minimum Eligible Age

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Ambika Ashraf, M.D.

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ambika Ashraf, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama

Birmingham, Alabama, United States

Site Status

Countries

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United States

References

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Alvarez JA, Gower BA, Calhoun DA, Judd SE, Dong Y, Dudenbostel T, Scholl J, Ashraf AP. Serum 25-hydroxyvitamin D and Ethnic Differences in Arterial Stiffness and Endothelial Function. J Clin Med Res. 2012 Jun;4(3):197-205. doi: 10.4021/jocmr965w. Epub 2012 May 15.

Reference Type DERIVED
PMID: 22719806 (View on PubMed)

Other Identifiers

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F091023002

Identifier Type: -

Identifier Source: org_study_id

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