Type 1 Diabetes MellitusNCT00933101
Vascular Inflammation in Adolescents With Type 1 Diabetes
An observational study of Type 1 Diabetes Mellitus and Coronary Artery Disease, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
The purpose of this study is to find out if diabetes damages the blood vessels of adolescents with good diabetes control compared to adolescents with less optimal control. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Type 1 Diabetes Mellitus, Coronary Artery Disease
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jun 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric Endocrinology clinic
Who may be able to join
- Adolescents ages 12-18 years
- Tanner stage III-V
- T1DM > 2 years
- HgbA1c <8 or >10 for previous 2 years
Who cannot join
- Subjects with known history of hypercholesterolemia or family history of hypercholesterolemia
- Family history of premature cardiovascular disease
- Hypertension defined as subjects with blood pressure greater than the 90th percentile for age
- Anemia defined as Hgb <11.0 g/dl
- ADHD
- Congenital heart disease
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- Pituitary tumor
- Known allergy to ultrasound gel
- Recent head injury
- Chromosomal abnormalities
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
About this study
Official title: Prevalence of Oxidative Stress, Endothelial Dysfunction, Increased Carotid Artery Intima-media Thickness (cIMT) and Biomarkers of Vascular Inflammation in Adolescents With Type-1 Diabetes Mellitus (T1DM)
The purpose of this study is to find out if diabetes damages the blood vessels of adolescents with good diabetes control compared to adolescents with less optimal control.
Read the detailed description
Many published studies reveal that adult patients with T1DM can have early, silent and more advanced vessel wall thickness than normal subjects. This is influenced by the degree of their blood sugar control. If this is happening in adolescents, we want to know what proportion of adolescent children with type 1 diabetes show signs of early blood vessel damage. We also want to learn if these signs of damage are linked to other factors such as how long someone has had diabetes, blood sugar control or individual differences because of a difference in genetic make-up.
- Conditions
- Type 1 Diabetes Mellitus, Coronary Artery Disease
- Medical subject headings
- Diabetes Mellitus, Type 1, Coronary Artery Disease
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 |
|---|---|---|
| HgbA1c <8 | Adolescents with HgbA1c < or equal to 8% for the previous 12 months | |
| HgbA1c >10 | Adolescents with HgbA1c > or equal to 10% for previous 12 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the impact of glycemic control on vascular oxidative stress/inflammation in adolescents with Type 1 diabetes mellitus
Measured: 1 year
Secondary outcomes (1)
To determine the impact of glycemic control and vascular oxidative stress/inflammation on vascular health in adolescents with T1DM
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2009 (estimated)
- Study startJan 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Investigators
- Ghufran Babar, MD, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00933101
- Sponsor's protocol ID
- 08 12-200E
- Status last verified
- Jun 2011
- First submitted
- 2 Jul 2009
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Oxidative Stress, Endothelial Dysfunction, Increased Carotid Artery Intima-media Thickness (cIMT) and Biomarkers of Vascular Inflammation in Adolescents With Type-1 Diabetes Mellitus (T1DM)
- ClinicalTrials.gov ID
- NCT00933101
- Acronym / sponsor ID
- 08 12-200E
- Conditions
- Type 1 Diabetes Mellitus, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 7 Jul 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 purpose of this study is to find out if diabetes damages the blood vessels of adolescents with good diabetes control compared to adolescents with less optimal control.
Detailed description
Many published studies reveal that adult patients with T1DM can have early, silent and more advanced vessel wall thickness than normal subjects. This is influenced by the degree of their blood sugar control. If this is happening in adolescents, we want to know what proportion of adolescent children with type 1 diabetes show signs of early blood vessel damage. We also want to learn if these signs of damage are linked to other factors such as how long someone has had diabetes, blood sugar control or individual differences because of a difference in genetic make-up.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HgbA1c <8 | – | –Adolescents with HgbA1c < or equal to 8% for the previous 12 months |
| HgbA1c >10 | – | –Adolescents with HgbA1c > or equal to 10% for previous 12 months |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric Endocrinology clinic
Key inclusion criteria (4 listed)
- Adolescents ages 12-18 years
- Tanner stage III-V
- T1DM > 2 years
- HgbA1c <8 or >10 for previous 2 years
Key exclusion criteria (10 listed)
- Subjects with known history of hypercholesterolemia or family history of hypercholesterolemia
- Family history of premature cardiovascular disease
- Hypertension defined as subjects with blood pressure greater than the 90th percentile for age
- Anemia defined as Hgb <11.0 g/dl
- ADHD
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
Determine the impact of glycemic control on vascular oxidative stress/inflammation in adolescents with Type 1 diabetes mellitus
Time frame: 1 year
1 secondary outcome
To determine the impact of glycemic control and vascular oxidative stress/inflammation on vascular health in adolescents with T1DM
Time frame: 1 year
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 27 Jun 2011.
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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.
Ghufran Babar, MD principal investigator
Children's Mercy Hospital Kansas City
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 Type 1 Diabetes Mellitus and Coronary Artery Disease, run by Children's Mercy Hospital Kansas City 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 4 inclusion and 10 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 27 Jun 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?
Determine the impact of glycemic control on vascular oxidative stress/inflammation in adolescents with Type 1 diabetes mellitus (time frame: 1 year). 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 27 Jun 2011.