Insulin SensitivityDIVANCT01041365
Vitamin D, Insulin Sensitivity, and Vascular Associations in Adolescents
An observational study of Insulin Sensitivity and Flow-mediated Dilation, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 14 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity, Flow-mediated Dilation, Arterial Stiffness
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Dec 2013
- 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 14 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Healthy adolescent African American and European American teenagers, ages 14-18, will be recruited form the Birmingham, AL community
Who may be able to join
- African American or Caucasian ethnicity
- Ages 14-18 yrs
- Healthy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum 25-hydroxyvitamin D, Vascular Functioning, and Insulin Sensitivity in Adolescent Girls [The DIVA Study (Vitamin D, Insulin, and Vascular Associations)] (Pediatric Physician Training in Translational Research)
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).
- Keywords
- insulin sensitivity, vascular function, flow-mediated dilation, arterial stiffness, ethnicity, adolescents, females, glucose tolerance, diabetes, hypertension, cardiovascular
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy adolescents | Healthy adolescent African American and Caucasian females, ages 14-18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity
Measured: Cross sectional study: at the first study visit
Secondary outcomes (1)
Vascular Function
Measured: Cross sectional study: at the second study visit, within 2 weeks of first study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2012
- Study completionDec 2013
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 Insulin SensitivityStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ambika Ashraf, M.D., University of Alabama at Birmingham
- Investigators
- Ambika Ashraf, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01041365
- Sponsor's protocol ID
- F090824002
- Acronym
- DIVA
- Status last verified
- Jan 2014
- First submitted
- 28 Dec 2009
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24170105Alvarez 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.
PubMed 22719806
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum 25-hydroxyvitamin D, Vascular Functioning, and Insulin Sensitivity in Adolescent Girls [The DIVA Study (Vitamin D, Insulin, and Vascular Associations)] (Pediatric Physician Training in Translational Research)
- ClinicalTrials.gov ID
- NCT01041365
- Acronym / sponsor ID
- DIVA / F090824002
- Keywords
- insulin sensitivity, vascular function, flow-mediated dilation, arterial stiffness, ethnicity, adolescents, females, glucose tolerance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 31 Dec 2009 (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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adolescents | – | –Healthy adolescent African American and Caucasian females, ages 14-18 |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Healthy adolescent African American and European American teenagers, ages 14-18, will be recruited form the Birmingham, AL community
Key inclusion criteria (3 listed)
- African American or Caucasian ethnicity
- Ages 14-18 yrs
- Healthy
Key exclusion criteria (4 listed)
- 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
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
Insulin Sensitivity
Time frame: Cross sectional study: at the first study visit
1 secondary outcome
Vascular Function
Time frame: Cross sectional study: at the second study visit, within 2 weeks of first study visit
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 14 Jan 2014.
- Derived from this study: PubMed 24170105Ashraf 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.
- Derived from this study: PubMed 22719806Alvarez 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.
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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.
Ambika Ashraf, MD principal investigator
University of Alabama at Birmingham
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 Insulin Sensitivity and Flow-mediated Dilation, run by University of Alabama at Birmingham 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 3 inclusion and 4 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 14 Jan 2014. 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?
Insulin Sensitivity (time frame: Cross sectional study: at the first study visit). 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 NCT01041365, 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 14 Jan 2014.