ObesityNCT01926938
Endothelial Function in Young Hispanic Adults at Risk for Type 2 Diabetes
An observational study of Obesity and Insulin Resistance, run by Joslin Diabetes Center at 1 site in United States.
Trial summary
Diabetes is a major public health problem. Hispanics/Latinos are known to be at higher risk for type 2 diabetes. The function of the endothelium has played a key role in the understanding of vascular complications in people with diabetes. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Insulin Resistance
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Jan 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Young Latino adults with and without family history of type 2 diabetes
Who may be able to join
- Group 1:
- Age between 18-40 years;
- Hispanic (we will consider a subject being Hispanic if both parents are reported as Hispanics when asked the following question: "What ethnic group do you consider that you belong to?");
- History of type 2 diabetes in one or both parents;
- BMI above 27;
- Not have participated in any exercise program for the 6 months prior to the beginning of the study.
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- Group 2:
- Age between 18-40 years;
- Hispanic (same criteria as above );
- No history of type 2 diabetes in any first degree relative;
- BMI under 25;
- Not have participated in any exercise program for the 6 months prior to the beginning of the study.
Who cannot join
- diabetes, glucose intolerance, pregnancy, smoking, cardiovascular disease, uncontrolled hypertension, renal disease, proteinuria, cancer, infectious diseases, severe GI diseases, lung disease, electrolyte abnormalities, anemia, endocrine disorders, severe dyslipidemia, peripheral vascular disease, medications: beta-blockers, any diuretic, calcium channel blockers, ACE inhibitors, angiotensin receptor blockers, niacin, glucocorticoids, any antineoplastic agent, antibiotics, psychoactive agents, bronchodilators or insulin.
Trial locations and contacts
1 site in 1 country.
About this study
Diabetes is a major public health problem. Hispanics/Latinos are known to be at higher risk for type 2 diabetes. The function of the endothelium has played a key role in the understanding of vascular complications in people with diabetes. Endothelial function and vascular reactivity are impaired not only in white adults with type 2 diabetes but also in those at risk for the disease by virtue of having impaired glucose tolerance or parental history of type 2 diabetes. Whether this finding is applicable to hispanics is not known. The investigators plan to assess the endothelial function and vascular reactivity in young Hispanic adults at risk of developing type 2 diabetes by virtue of being obese and belonging to a minority population.
- Conditions
- Obesity, Insulin Resistance
- Medical subject headings
- Obesity, Insulin Resistance
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 |
|---|---|---|
| adults at risk | Latino adults with family history of type 2 diabetes | |
| controls | Latino adults without family history of type 2 diabetes and normal glucose tolerance |
What is being measured
The primary outcome is the main question the study is designed to answer.
markers of endothelial activation, coagulation and inflammation
Measured: cross sectional evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2013 (estimated)
- Study startMay 2003
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrique Caballero, Joslin Diabetes Center
- Investigators
- Enrique Caballero, MD, Principal investigator, Joslin Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926938
- Sponsor's protocol ID
- CHS#: 03-30
- Status last verified
- Aug 2013
- First submitted
- 19 Aug 2013
- Last updated
- 21 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Function in Young Hispanic Adults at Risk for Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01926938
- Acronym / sponsor ID
- CHS#: 03-30
- Conditions
- Obesity, Insulin Resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Study start
- May 2003
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 21 Aug 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.
Diabetes is a major public health problem. Hispanics/Latinos are known to be at higher risk for type 2 diabetes. The function of the endothelium has played a key role in the understanding of vascular complications in people with diabetes. Endothelial function and vascular reactivity are impaired not only in white adults with type 2 diabetes but also in those at risk for the disease by virtue of having impaired glucose tolerance or parental history of type 2 diabetes. Whether this finding is applicable to hispanics is not known. The investigators plan to assess the endothelial function and vascular reactivity in young Hispanic adults at risk of developing type 2 diabetes by virtue of being obese and belonging to a minority population.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adults at risk | – | –Latino adults with family history of type 2 diabetes |
| controls | – | –Latino adults without family history of type 2 diabetes and normal glucose tolerance |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young Latino adults with and without family history of type 2 diabetes
Key inclusion criteria (12 listed)
- Group 1:
- Age between 18-40 years;
- Hispanic (same criteria as above );
- No history of type 2 diabetes in any first degree relative;
- BMI under 25;
Key exclusion criteria (1 listed)
- diabetes, glucose intolerance, pregnancy, smoking, cardiovascular disease, uncontrolled hypertension, renal disease, proteinuria, cancer, infectious diseases, severe GI diseases, lung disease, electrolyte abnormalities, anemia, endocrine disorders, severe dyslipidemia, peripheral vascular disease, medications: beta-blockers, any diuretic, calcium channel blockers, ACE inhibitors, angiotensin receptor blockers, niacin, glucocorticoids, any antineoplastic agent, antibiotics, psychoactive agents, bronchodilators or insulin.
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
markers of endothelial activation, coagulation and inflammation
Time frame: cross sectional evaluation
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 21 Aug 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.
Enrique Caballero, MD principal investigator
Joslin Diabetes Center
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 Obesity and Insulin Resistance, run by Joslin Diabetes Center 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 12 inclusion and 1 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 21 Aug 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?
markers of endothelial activation, coagulation and inflammation (time frame: cross sectional evaluation). 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 21 Aug 2013.