Arterial Stiffness in Youth With Type 1 DiabetesNCT02218268
Arterial Stiffness in Type I Diabetes Mellitus
An observational study of Arterial Stiffness in Youth With Type 1 Diabetes, run by University of Florida at 1 site in United States.
Trial summary
Using radial artery tonometry to study arterial stiffness, the plan is to study a cohort of 65 children with Type I diabetes mellitus. This prospective, crossover study will help determine if there is an acute increase in arterial stiffness in children with Type I diabetes mellitus who do not give extra insulin to… Read more about this study
- Who is it for?
- Ages 8 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Arterial Stiffness in Youth With Type 1 Diabetes
- What is being tested?
- Pre-meal bolus and No meal bolus
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Aug 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: University of Florida diabetes clinic and the Florida Camp for Children and Youth with Diabetes. Subjects had type 1 diabetes for at least one year, were using a basal-bolus insulin regimen, and were not taking oral hypoglycemic agents or antihypertensive drugs.
Who may be able to join
- Type 1 diabetes based on clinical history
- Basal-bolus insulin regimen
- Duration of diabetes greater than 1 year
- Blood glucose 65-200 mg/dL fasting
Who cannot join
- Use of metformin or any other hypoglycemic agents besides insulin
- Use of anti-hypertensives
- Caffeine or smoking within the past 24 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effect of a Mixed Meal With and Without Extra Insulin on Arterial Stiffness, a Prospective Randomized Study.
Using radial artery tonometry to study arterial stiffness, the plan is to study a cohort of 65 children with Type I diabetes mellitus. This prospective, crossover study will help determine if there is an acute increase in arterial stiffness in children with Type I diabetes mellitus who do not give extra insulin to cover a meal. This will give more support to show why it is so critical to bolus every time they eat and to bolus on time to decrease cardiovascular consequences of poorly controlled diabetes. The hypothesis is that giving insulin before a meal compared to not giving insulin before a meal will be associated with lower arterial stiffness in children with type I diabetes.
Read the detailed description
The subject will fast overnight (nothing to eat or drink for at least 8 hours). The subject will be asked to drink a mixed meal replacement drink (Boost) and will be randomized (like flipping a coin) to bolus insulin for the "meal" or to not bolus insulin using their standard insulin dose. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement.
Stiffness of the blood vessel of the wrist will be determined using radial tonometry. Radial tonometry is safe and does not hurt. A pen like probe is placed on the blood vessel of the wrist. When the machine reads a good wave form the computer will calculate the stiffness of the blood vessel. This test will be done along with the glucose checks; before drinking the meal replacement drink, and 1 and 2 hours after drinking the meal replacement drink.
During the next study visit, the subject will repeat the exact same study described above. However, this time they will receive the other insulin assignment they were assigned during the first study (either bolus or no bolus).
- Being tested
- Pre-meal bolus, No meal bolus
- Keywords
- type I diabetes, healthy, children, adolescents, young adults
- 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.
Pre-meal bolusDrug
Long acting insulin as scheduled per usual routine PLUS rapid/ short acting (bolus) prior to Boost
No meal bolusDrug
Long Acting insulin as scheduled per usual routine (given once daily)
| Study group | Role | What they receive |
|---|---|---|
| Pre-meal bolus then No meal bolus | A meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.
Then 3 months later A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring Receives: Drug: Pre-meal bolus; Drug: No meal bolus | |
| No meal bolus then Pre-meal bolus | A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.
Then 3 months later meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring Receives: Drug: Pre-meal bolus; Drug: No meal bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the Difference Between Acute Effect of a Mixed Meal on Radial Artery Stiffness in Subjects With Type I Diabetes Mellitus Who do and Who do Not Take an Additional Bolus of Insulin.
Determine the difference between acute effect of a mixed meal on radial artery stiffness in subjects with type I diabetes mellitus who do and who do not take an additional bolus of insulin. Radial tonometry is used to calculate the augmentation index (AI). AI is expressed as a percentage of the pulse pressure and represents the difference between the first and second peaks of the central arterial waveform. The stiffer the artery the more positive elevation of the AI and the machine will indicate stiffness using a color indicator (green less stiff and red being stiff). AI is measured using the SphygmoCor VX version 7.01 (AtCor Medical, Syndey, Australia). AI will be corrected to a heart rate of 75 to eliminate differences related to heart rate variation.
Measured: From baseline to one hour then 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arterial Stiffness in Youth With Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Diabetes Action Research and Education Foundation
- Responsible party
- Sponsor
- Investigators
- Michael Haller, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218268
- Sponsor's protocol ID
- IRB201400553
- Other IDs
- 00093792
- Status last verified
- Dec 2016
- First submitted
- 8 Aug 2014
- Last updated
- 6 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of a Mixed Meal With and Without Extra Insulin on Arterial Stiffness, a Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT02218268
- Acronym / sponsor ID
- IRB201400553
- Keywords
- type I diabetes, healthy, children, adolescents, young adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Diabetes Action Research and Education Foundation
- Study start
- Oct 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 18 Aug 2014 (estimated)
- Results
- Posted 6 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Using radial artery tonometry to study arterial stiffness, the plan is to study a cohort of 65 children with Type I diabetes mellitus. This prospective, crossover study will help determine if there is an acute increase in arterial stiffness in children with Type I diabetes mellitus who do not give extra insulin to cover a meal. This will give more support to show why it is so critical to bolus every time they eat and to bolus on time to decrease cardiovascular consequences of poorly controlled diabetes. The hypothesis is that giving insulin before a meal compared to not giving insulin before a meal will be associated with lower arterial stiffness in children with type I diabetes.
Detailed description
The subject will fast overnight (nothing to eat or drink for at least 8 hours). The subject will be asked to drink a mixed meal replacement drink (Boost) and will be randomized (like flipping a coin) to bolus insulin for the "meal" or to not bolus insulin using their standard insulin dose. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement.
Stiffness of the blood vessel of the wrist will be determined using radial tonometry. Radial tonometry is safe and does not hurt. A pen like probe is placed on the blood vessel of the wrist. When the machine reads a good wave form the computer will calculate the stiffness of the blood vessel. This test will be done along with the glucose checks; before drinking the meal replacement drink, and 1 and 2 hours after drinking the meal replacement drink.
During the next study visit, the subject will repeat the exact same study described above. However, this time they will receive the other insulin assignment they were assigned during the first study (either bolus or no bolus).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-meal bolus then No meal bolus | – | Drug: Pre-meal bolus, Drug: No meal bolusA meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring. Then 3 months later A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring |
| No meal bolus then Pre-meal bolus | – | Drug: Pre-meal bolus, Drug: No meal bolusA meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring. Then 3 months later meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- University of Florida diabetes clinic and the Florida Camp for Children and Youth with Diabetes. Subjects had type 1 diabetes for at least one year, were using a basal-bolus insulin regimen, and were not taking oral hypoglycemic agents or antihypertensive drugs.
Key inclusion criteria (4 listed)
- Type 1 diabetes based on clinical history
- Basal-bolus insulin regimen
- Duration of diabetes greater than 1 year
- Blood glucose 65-200 mg/dL fasting
Key exclusion criteria (3 listed)
- Use of metformin or any other hypoglycemic agents besides insulin
- Use of anti-hypertensives
- Caffeine or smoking within the past 24 hours
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 |
|---|---|---|
| Pre-meal bolusLong acting insulin as scheduled per usual routine PLUS rapid/ short acting (bolus) prior to Boost | Drug | No meal bolus then Pre-meal bolus, Pre-meal bolus then No meal bolus |
| No meal bolusLong Acting insulin as scheduled per usual routine (given once daily) | Drug | No meal bolus then Pre-meal bolus, Pre-meal bolus then No meal bolus |
Primary outcome
Determine the Difference Between Acute Effect of a Mixed Meal on Radial Artery Stiffness in Subjects With Type I Diabetes Mellitus Who do and Who do Not Take an Additional Bolus of Insulin.
Time frame: From baseline to one hour then 2 hours
Determine the difference between acute effect of a mixed meal on radial artery stiffness in subjects with type I diabetes mellitus who do and who do not take an additional bolus of insulin. Radial tonometry is used to calculate the augmentation index (AI). AI is expressed as a percentage of the pulse pressure and represents the difference between the first and second peaks of the central arterial waveform. The stiffer the artery the more positive elevation of the AI and the machine will indicate stiffness using a color indicator (green less stiff and red being stiff). AI is measured using the SphygmoCor VX version 7.01 (AtCor Medical, Syndey, Australia). AI will be corrected to a heart rate of 75 to eliminate differences related to heart rate variation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Arterial Stiffness in Youth With Type 1 Diabetes
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Vascular Complications in Children From T1D Diagnosis
Type 1 Diabetes, Cardiovascular Complications
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.
Michael Haller, MD principal investigator
University of Florida
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 Arterial Stiffness in Youth With Type 1 Diabetes, run by University of Florida 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 3 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 6 Feb 2017. 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?
Yes. Results are posted in the registry (first posted 6 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Difference Between Acute Effect of a Mixed Meal on Radial Artery Stiffness in Subjects With Type I Diabetes Mellitus Who do and Who do Not Take an Additional Bolus of Insulin. (time frame: From baseline to one hour then 2 hours). 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 6 Feb 2017.