Insulin ResistanceNCT01831102
Adiponectin and Ethnic Differences in Insulin Resistance
An observational study of Insulin Resistance and Type 2 Diabetes, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this protocol is to measure and compare levels of the circulating protein adiponectin and adiponectin's association with insulin sensitivity in Mexican Americans and non-Latino white subjects. The investigators also aimed to examine associations between nutritional factors and adiponectin levels. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Type 2 Diabetes
- What is being tested?
- none- observational study
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Aug 2011
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Community sample
Who may be able to join
- 18-60 years of age
- BMI 20.0-34.9 m/kg2
- Mexican American with at least 3 grandparents born in Mexico or white with no grandparents of Latino descent.
Who cannot join
- pregnancy
- breastfeeding
- diabetes mellitus
- blood pressure > 160/100 mmHg
- creatinine > 1.5 mg/dl or glomerular filtration rate (GFR) < 60
- liver function tests > 3x upper limit of normal (ULN)
- h/o heart failure
- h/o eating disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Center
Aurora, Colorado, 80045
About this study
Official title: Adiponectin as an Independent Determinant of Ethnic Differences in Insulin Resistance
The purpose of this protocol is to measure and compare levels of the circulating protein adiponectin and adiponectin's association with insulin sensitivity in Mexican Americans and non-Latino white subjects. The investigators also aimed to examine associations between nutritional factors and adiponectin levels.
- Conditions
- Insulin Resistance, Type 2 Diabetes
- Being tested
- none- observational study
- Keywords
- insulin resistance, ethnic disparities, adiponectin
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
none- observational studyOther
| Study group | Role | What they receive |
|---|---|---|
| non-Latino white | no Latino ancestry, Caucasian Receives: Other: none- observational study | |
| Mexican American | Mexican American ancestry Receives: Other: none- observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
total adiponectin concentration
Measured: measured once during second study visit, in fasting condition
Secondary outcomes (1)
Insulin sensitivity
Calculated from insulin and glucose values obtained during IV glucose tolerance test.
Measured: Measured once, during second study visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startMar 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rocio Pereira, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831102
- Sponsor's protocol ID
- 10-1260
- Status last verified
- Apr 2013
- First submitted
- 5 Apr 2013
- Last updated
- 15 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adiponectin as an Independent Determinant of Ethnic Differences in Insulin Resistance
- ClinicalTrials.gov ID
- NCT01831102
- Acronym / sponsor ID
- 10-1260
- Conditions
- Insulin Resistance, Type 2 Diabetes
- Keywords
- insulin resistance, ethnic disparities, adiponectin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 15 Apr 2013 (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 purpose of this protocol is to measure and compare levels of the circulating protein adiponectin and adiponectin's association with insulin sensitivity in Mexican Americans and non-Latino white subjects. The investigators also aimed to examine associations between nutritional factors and adiponectin levels.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-Latino white | – | Other: none- observational studyno Latino ancestry, Caucasian |
| Mexican American | – | Other: none- observational studyMexican American ancestry |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community sample
Key inclusion criteria (3 listed)
- 18-60 years of age
- BMI 20.0-34.9 m/kg2
- Mexican American with at least 3 grandparents born in Mexico or white with no grandparents of Latino descent.
Key exclusion criteria (8 listed)
- pregnancy
- breastfeeding
- diabetes mellitus
- blood pressure > 160/100 mmHg
- creatinine > 1.5 mg/dl or glomerular filtration rate (GFR) < 60
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| none- observational study | Other | Mexican American, non-Latino white |
Primary outcome
total adiponectin concentration
Time frame: measured once during second study visit, in fasting condition
1 secondary outcome
Insulin sensitivity
Time frame: Measured once, during second 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 15 Apr 2013.
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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.
Rocio Pereira, MD principal investigator
University of Colorado, Denver
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 Resistance and Type 2 Diabetes, run by University of Colorado, Denver 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 8 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 15 Apr 2013. 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?
total adiponectin concentration (time frame: measured once during second study visit, in fasting condition). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2013.