Type 1 DiabetesNCT00348179
Vascular Function in Adolescent, Diabetic Children
A study testing Measurement of vascular function per SphymgnoCor equipment in people with Type 1 Diabetes, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
The objectives of this investigator initiated study are to: 1. Determine if and when vascular abnormalities occur during early adolescence 2. Determine if poor diabetic control is related to vascular abnormalities. Read more about this study
- Who is it for?
- Ages 12 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Measurement of vascular function per SphymgnoCor equipment
- Type of treatment
- Surgery or procedure
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Apr 2007
- Phase
- Interventional
- 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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Boys and girls ages 12-14 years who have Type 1 diabetes or are healthy controls
Who cannot join
- Children and adolescents who do not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
The objectives of this investigator initiated study are to:
- Determine if and when vascular abnormalities occur during early adolescence
- Determine if poor diabetic control is related to vascular abnormalities.
The development of vascular plaques and vascular contractility will be assessed through the use of the SyphmgnoCor equipment.
Read the detailed description
Up to 85 Type 1 diabetic and healthy controls, 12-14 years of age, will be recruited for the study. Once the Permission/Assent form has been completed, a cuff will be applied to the arm and the pressure tonometer will be used on various vessels. Cardiovascular data will be recorded. The procedure is non-invasive, will last approximately 10 minutes and will be performed during a routine clinic visit. Onset of diabetes and level of diabetic control as measured by the most recent Hbg A1c (relative to the study visit) will be obtained from the medical record. Microalbumin levels covering the prior 12 months will be collected from the medical record of diabetic subjects.
- Conditions
- Type 1 Diabetes
- Being tested
- Measurement of vascular function per SphymgnoCor equipment
- Keywords
- Vascular abnormalities, Type 1 diabetes, Healthy control subjects
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of vascular function per SphymgnoCor equipmentProcedure or surgery
Pressure tonometer will be used on various vessels, non-invasive.
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular abnormalities as measured by the SyphmgnoCor equipment
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startApr 2004
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Investigators
- Kurt Midyett, MD, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00348179
- Sponsor's protocol ID
- 04 04-036E
- Status last verified
- Apr 2007
- First submitted
- 30 Jun 2006
- Last updated
- 24 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Function in Adolescent, Diabetic Children
- ClinicalTrials.gov ID
- NCT00348179
- Acronym / sponsor ID
- 04 04-036E
- Conditions
- Type 1 Diabetes
- Keywords
- Vascular abnormalities, Type 1 diabetes, Healthy control subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 4 Jul 2006 (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 objectives of this investigator initiated study are to:
- Determine if and when vascular abnormalities occur during early adolescence
- Determine if poor diabetic control is related to vascular abnormalities.
The development of vascular plaques and vascular contractility will be assessed through the use of the SyphmgnoCor equipment.
Detailed description
Up to 85 Type 1 diabetic and healthy controls, 12-14 years of age, will be recruited for the study. Once the Permission/Assent form has been completed, a cuff will be applied to the arm and the pressure tonometer will be used on various vessels. Cardiovascular data will be recorded. The procedure is non-invasive, will last approximately 10 minutes and will be performed during a routine clinic visit. Onset of diabetes and level of diabetic control as measured by the most recent Hbg A1c (relative to the study visit) will be obtained from the medical record. Microalbumin levels covering the prior 12 months will be collected from the medical record of diabetic subjects.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Boys and girls ages 12-14 years who have Type 1 diabetes or are healthy controls
Key exclusion criteria (1 listed)
- Children and adolescents who do not meet inclusion criteria
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 |
|---|---|---|
| Measurement of vascular function per SphymgnoCor equipmentPressure tonometer will be used on various vessels, non-invasive. | Procedure or surgery | – |
Primary outcome
Vascular abnormalities as measured by the SyphmgnoCor equipment
Time frame: End of study
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 24 Jan 2008.
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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.
Kurt Midyett, 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?
A study testing Measurement of vascular function per SphymgnoCor equipment in people with Type 1 Diabetes, 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 1 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 24 Jan 2008. 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?
Vascular abnormalities as measured by the SyphmgnoCor equipment (time frame: End of study). 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 24 Jan 2008.