Vitamin D, Insulin Sensitivity, and Vascular Associations in Adolescents

NCT ID: NCT01041365

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

62 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 AA is responsible for ethnic differences in insulin sensitivity and hypertension in AA and 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 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), 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 adolescents

Healthy adolescent African American and Caucasian females, ages 14-18

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* African American or Caucasian ethnicity
* Ages 14-18 yrs
* Healthy

Exclusion Criteria

* BMI-for age and -sex higher than 95th centile on the Centers for Disease Control and Prevention Growth Charts
* Use of medication(s) known to influence body composition, vascular function, or glucose metabolism
* Pregnancy
* Diabetes or any chronic diseases
Minimum Eligible Age

14 Years

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

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, Pediatrics

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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Ashraf AP, Huisingh C, Alvarez JA, Wang X, Gower BA. Insulin resistance indices are inversely associated with vitamin D binding protein concentrations. J Clin Endocrinol Metab. 2014 Jan;99(1):178-83. doi: 10.1210/jc.2013-2452. Epub 2013 Dec 20.

Reference Type DERIVED
PMID: 24170105 (View on PubMed)

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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F090824002

Identifier Type: -

Identifier Source: org_study_id

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