Peripheral Artery TonometryNCT01267591
Peripheral Artery Tonometry in Children With Type 1 Diabetes and Obese Children
An observational study of Peripheral Artery Tonometry and Diabetes, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Background: The reactive hyperemia-peripheral artery tonometry (RH-PAT) is a newly developed method for noninvasive endothelial function assessment. Objective: The goal of this study is to determine whether a significant difference in RH-PAT score is present between adolescents with type 1 diabetes (T1D) in comparison… Read more about this study
- Who is it for?
- Ages 12 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Artery Tonometry, Diabetes, Children
- How many people
- 70 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2009to Jun 2025
- 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 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: children seen at consultation in University Hospital
Who may be able to join
- 12-19 years of age
Who cannot join
- type 2 diabetes; obesity in group of type 1 diabetes
Trial locations and contacts
1 site in 1 country.
kristina casteels, MD Phd contact
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Leuven
Leuven
kristina casteels, MD PhD, 00-32-16-343801
About this study
Official title: Peripheral Artery Tonometry in Children With Type 1 Diabetes and Obese Children.
Background: The reactive hyperemia-peripheral artery tonometry (RH-PAT) is a newly developed method for noninvasive endothelial function assessment.
Objective: The goal of this study is to determine whether a significant difference in RH-PAT score is present between adolescents with type 1 diabetes (T1D) in comparison with controls. We will also compare RH-PAT scores in obese adolescents versus controls.
- Conditions
- Peripheral Artery Tonometry, Diabetes, Children, Obesity
- Medical subject headings
- Diabetes Mellitus, 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 |
|---|---|---|
| control | Not described | |
| type 1 diabetes | Not described | |
| obesity | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
RHPAT
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2010 (estimated)
- Study startJan 2009
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery TonometryStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01267591
- Sponsor's protocol ID
- UZLeuven
- Status last verified
- Jun 2024
- First submitted
- 27 Dec 2010
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pareyn A, Allegaert K, Verhamme P, Vinckx J, Casteels K. Impaired endothelial function in adolescents with overweight or obesity measured by peripheral artery tonometry. Pediatr Diabetes. 2015 Mar;16(2):98-103. doi: 10.1111/pedi.12139. Epub 2014 Apr 3.
PubMed 24698176
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Artery Tonometry in Children With Type 1 Diabetes and Obese Children.
- ClinicalTrials.gov ID
- NCT01267591
- Acronym / sponsor ID
- UZLeuven
- Conditions
- Peripheral Artery Tonometry, Diabetes, Children, Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jan 2009 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 28 Dec 2010 (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.
Background: The reactive hyperemia-peripheral artery tonometry (RH-PAT) is a newly developed method for noninvasive endothelial function assessment.
Objective: The goal of this study is to determine whether a significant difference in RH-PAT score is present between adolescents with type 1 diabetes (T1D) in comparison with controls. We will also compare RH-PAT scores in obese adolescents versus controls.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | – | – |
| type 1 diabetes | – | – |
| obesity | – | – |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- children seen at consultation in University Hospital
Key inclusion criteria (1 listed)
- 12-19 years of age
Key exclusion criteria (1 listed)
- type 2 diabetes; obesity in group of type 1 diabetes
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
RHPAT
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Derived from this study: PubMed 24698176Pareyn A, Allegaert K, Verhamme P, Vinckx J, Casteels K. Impaired endothelial function in adolescents with overweight or obesity measured by peripheral artery tonometry. Pediatr Diabetes. 2015 Mar;16(2):98-103. doi: 10.1111/pedi.12139. Epub 2014 Apr 3.
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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.
kristina casteels, MD Phd contact
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 Peripheral Artery Tonometry and Diabetes, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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: status not confirmed, as of the sponsor's last update on 1 Jul 2024. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact kristina casteels, MD Phd (00-32-16-343801), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RHPAT (time frame: 2 years). 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 NCT01267591, which also lists 1 linked publication.
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 1 Jul 2024.