HealthyAMERICONCT00726778
Admixture Mapping of Ethnic and Racial Insulin Complex Outcomes
An observational study of Healthy, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The main objective of this study is to investigate the effect of genetic and environmental parameters on racial/ethnic differences in aspects of insulin secretion and action. The genetic component will be modeled by estimating the degree of European genetic admixture (ADM) obtained from approximately 50 ancestry… Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Dec 2010
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 120 African Americans, 120 European Americans and 120 Hispanic Americans (60 males and 60 females per group). To minimize the influence of puberty on SI and AIRg, recruitment will be limited to individuals between ages 7-12, a range that based on previous observations from our team, categorize children from Tanner stage 1 and 2.
Who may be able to join
- African American, European American, or Hispanic American, aged 7-12, healthy, weight is equal to or greater than 25 Kg
Who cannot join
- Type 1 or 2 diabetes, polycystic ovary disease, disturbances in glucose or lipid metabolism disturbances
- Use of medication known to affect body composition or physical activity, diagnosis of genetic disorders known to affect body composition or fat distribution
- Use of tobacco, alcohol consumption in excess of 400 g per week
- Menstruated for more than a year prior to the recruitment; OR
- A medical history that counter-indicates inclusion of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
The main objective of this study is to investigate the effect of genetic and environmental parameters on racial/ethnic differences in aspects of insulin secretion and action. The genetic component will be modeled by estimating the degree of European genetic admixture (ADM) obtained from approximately 50 ancestry informative markers (AIMs). The environmental components will be modeled by measuring energy intake (food intake), energy expenditure (physical activity) and socioeconomic status.
- Conditions
- Healthy
- Keywords
- race/ethnicity, insulin senistivity, genetic admixture, type 2 diabetes, obesity, body composition, Insulin dynamics, Racial/ethnic differences
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
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 |
|---|---|---|
| A, Observational | Healthy European American, African American, and Hispanic American children aged 7-12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To test the role of European genetic admixture on measures of insulin action and response in a multiethnic group of prepubertal children.
Measured: 5 years
To investigate whether the impact of energy intake, energy expenditure and socioeconomic status on proxy measures of insulin sensitivity and/or action differ as a function of European ADM in prepubertal children
Measured: 5 years
To test phenotype-genotype associations between each one of the AIMs and measures of FI, SI and AIRg after adjusting for body composition in a sample of AA, HA and EA prepubertal children.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startMay 2004
- Primary completionDec 2008
- Study completionDec 2010
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 HealthyStudies 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
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Investigators
- Jose Fernandez, Ph.D., Principal investigator, UA B
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726778
- Sponsor's protocol ID
- F040109007
- Other IDs
- R01DK067426
- Acronym
- AMERICO
- Status last verified
- Mar 2011
- First submitted
- 29 Jul 2008
- Last updated
- 16 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Cardel M, Lemas DJ, Jackson KH, Friedman JE, Fernandez JR. Higher Intake of PUFAs Is Associated with Lower Total and Visceral Adiposity and Higher Lean Mass in a Racially Diverse Sample of Children. J Nutr. 2015 Sep;145(9):2146-52. doi: 10.3945/jn.115.212365. Epub 2015 Aug 12.
PubMed 26269238Kell KP, Cardel MI, Bohan Brown MM, Fernandez JR. Added sugars in the diet are positively associated with diastolic blood pressure and triglycerides in children. Am J Clin Nutr. 2014 Jul;100(1):46-52. doi: 10.3945/ajcn.113.076505. Epub 2014 Apr 9.
PubMed 24717340
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Admixture Mapping of Ethnic and Racial Insulin Complex Outcomes
- ClinicalTrials.gov ID
- NCT00726778
- Acronym / sponsor ID
- AMERICO / F040109007
- Conditions
- Healthy
- Keywords
- race/ethnicity, insulin senistivity, genetic admixture, type 2 diabetes, obesity, body composition, Insulin dynamics, Racial/ethnic differences
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- May 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 1 Aug 2008 (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 main objective of this study is to investigate the effect of genetic and environmental parameters on racial/ethnic differences in aspects of insulin secretion and action. The genetic component will be modeled by estimating the degree of European genetic admixture (ADM) obtained from approximately 50 ancestry informative markers (AIMs). The environmental components will be modeled by measuring energy intake (food intake), energy expenditure (physical activity) and socioeconomic status.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A, Observational | – | –Healthy European American, African American, and Hispanic American children aged 7-12 |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 120 African Americans, 120 European Americans and 120 Hispanic Americans (60 males and 60 females per group). To minimize the influence of puberty on SI and AIRg, recruitment will be limited to individuals between ages 7-12, a range that based on previous observations from our team, categorize children from Tanner stage 1 and 2.
Key inclusion criteria (1 listed)
- African American, European American, or Hispanic American, aged 7-12, healthy, weight is equal to or greater than 25 Kg
Key exclusion criteria (5 listed)
- Type 1 or 2 diabetes, polycystic ovary disease, disturbances in glucose or lipid metabolism disturbances
- Use of medication known to affect body composition or physical activity, diagnosis of genetic disorders known to affect body composition or fat distribution
- Use of tobacco, alcohol consumption in excess of 400 g per week
- Menstruated for more than a year prior to the recruitment; OR
- A medical history that counter-indicates inclusion of the study
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
To test the role of European genetic admixture on measures of insulin action and response in a multiethnic group of prepubertal children.
Time frame: 5 years
To investigate whether the impact of energy intake, energy expenditure and socioeconomic status on proxy measures of insulin sensitivity and/or action differ as a function of European ADM in prepubertal children
Time frame: 5 years
To test phenotype-genotype associations between each one of the AIMs and measures of FI, SI and AIRg after adjusting for body composition in a sample of AA, HA and EA prepubertal children.
Time frame: 5 years
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 16 Mar 2011.
- Derived from this study: PubMed 26269238Cardel M, Lemas DJ, Jackson KH, Friedman JE, Fernandez JR. Higher Intake of PUFAs Is Associated with Lower Total and Visceral Adiposity and Higher Lean Mass in a Racially Diverse Sample of Children. J Nutr. 2015 Sep;145(9):2146-52. doi: 10.3945/jn.115.212365. Epub 2015 Aug 12.
- Derived from this study: PubMed 24717340Kell KP, Cardel MI, Bohan Brown MM, Fernandez JR. Added sugars in the diet are positively associated with diastolic blood pressure and triglycerides in children. Am J Clin Nutr. 2014 Jul;100(1):46-52. doi: 10.3945/ajcn.113.076505. Epub 2014 Apr 9.
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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.
Jose Fernandez, Ph.D. principal investigator
UA B
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 Healthy, 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 1 inclusion and 5 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 16 Mar 2011. 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?
To test the role of European genetic admixture on measures of insulin action and response in a multiethnic group of prepubertal children. (time frame: 5 years). The study lists 3 primary outcomes in all. 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 NCT00726778, 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 16 Mar 2011.