DiabetesNCT00259701
Microvascular Reactivity.
An observational study of Diabetes and Retinopathy, run by Yale University at 1 site in United States.
Trial summary
This study attempts to test capillary responses to various challenges without the need for iontophoresis (electrical current). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Retinopathy, Vascular Pathology
- What is being tested?
- Laser Doppler Flowmetry with topical acetylcholine and nitroglycerin
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Sep 2005
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Exclusion Criteria: not on nitrates or mydriatic eye drops within 48 hours.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06510
About this study
Official title: Transdermal Application of Acetylcholine and Nitroglycerin Without Iontophoresis.
This study attempts to test capillary responses to various challenges without the need for iontophoresis (electrical current).
Read the detailed description
Studies of microvascular responsiveness often employ iontophoresis to fascilitate drug absorption. Iontophoresis is a confounding stimulus in such studies, and we are attempting to create tests of the microvasculature that do not require iontophoretic drug delivery.
- Conditions
- Diabetes, Retinopathy, Vascular Pathology
- Being tested
- Laser Doppler Flowmetry with topical acetylcholine and nitroglycerin
- Keywords
- endothelium, iontophoresis, acetylcholine, nitroglycerin, vasodilation
- Medical subject headings
- Diabetes Mellitus, Retinal Diseases, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Doppler Flowmetry with topical acetylcholine and nitroglycerinDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2005 (estimated)
- Study startJun 2005
- Study completionSep 2005
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 DiabetesStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Defined population
- Time perspective
- Other
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Investigators
- David G Silverman, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259701
- Sponsor's protocol ID
- HIC-12397-1
- Status last verified
- Nov 2005
- First submitted
- 28 Nov 2005
- Last updated
- 6 Oct 2006
- Results posted
- No
Publications
Schonberger RB, Worden WS, Shahmohammadi K, Menn K, Silverman TJ, Stout RG, Shelley KH, Silverman DG. Topical non-iontophoretic application of acetylcholine and nitroglycerin via a translucent patch: a new means for assessing microvascular reactivity. Yale J Biol Med. 2006 Mar;79(1):1-7.
PubMed 17876370
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdermal Application of Acetylcholine and Nitroglycerin Without Iontophoresis.
- ClinicalTrials.gov ID
- NCT00259701
- Acronym / sponsor ID
- HIC-12397-1
- Conditions
- Diabetes, Retinopathy, Vascular Pathology
- Keywords
- endothelium, iontophoresis, acetylcholine, nitroglycerin, vasodilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jun 2005
- Study completion
- Sep 2005
- First posted
- 29 Nov 2005 (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.
This study attempts to test capillary responses to various challenges without the need for iontophoresis (electrical current).
Detailed description
Studies of microvascular responsiveness often employ iontophoresis to fascilitate drug absorption. Iontophoresis is a confounding stimulus in such studies, and we are attempting to create tests of the microvasculature that do not require iontophoretic drug delivery.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Exclusion Criteria: not on nitrates or mydriatic eye drops within 48 hours.
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Laser Doppler Flowmetry with topical acetylcholine and nitroglycerin | Device | – |
Primary outcome
Not reported in the source record.
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 6 Oct 2006.
- Derived from this study: PubMed 17876370Schonberger RB, Worden WS, Shahmohammadi K, Menn K, Silverman TJ, Stout RG, Shelley KH, Silverman DG. Topical non-iontophoretic application of acetylcholine and nitroglycerin via a translucent patch: a new means for assessing microvascular reactivity. Yale J Biol Med. 2006 Mar;79(1):1-7.
Related trials for Diabetes
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Active, not recruitingObservational study
EFFECT OF HYBRID CLOSED-LOOP SYSTEMS ON CARDIOVASCULAR MARKERS IN TYPE 1 DIABETES.
Type 1 Diabetes
Active, not recruiting
Effect of the Thrive AI Health App on Lifestyle Behaviors and Quality of Life
Diabetes Type 2, Overweight or Obesity
RecruitingObservational study
A Natural History Study of Metabolic Sizing in Health and Disease
Metabolic Disorders, Cancer
Recruiting
Insulin-Mediated Glucose Uptake and Organ Perfusion Assessed by Total-Body PET During GIP and GLP-1 Infusion
Type 2 Diabetes, Healhty
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.
David G Silverman principal investigator
Yale University
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 Diabetes and Retinopathy, run by Yale University 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 2 inclusion and 0 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 Oct 2006. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00259701, 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 6 Oct 2006.