Microvascular Reactivity. - Tabular View

Tracking Information

First Received Date ^ICMJE

November 28, 2005

Last Updated Date

October 5, 2006

Start Date ^ICMJE

June 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00259701 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Microvascular Reactivity.

Official Title ^ICMJE

Transdermal Application of Acetylcholine and Nitroglycerin Without Iontophoresis.

Brief Summary

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 Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Screening, Cross-Sectional, Defined Population, Prospective Study

Condition ^ICMJE

Diabetes
Retinopathy
Vascular Pathology

Intervention ^ICMJE

Device: Laser Doppler Flowmetry with topical acetylcholine and nitroglycerin

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria: diabetic. -

Exclusion Criteria: not on nitrates or mydriatic eye drops within 48 hours.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00259701

Responsible Party

Study ID Numbers ^ICMJE

HIC-12397-1

Study Sponsor ^ICMJE

Yale University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

David G Silverman

Yale School of Medicine

Information Provided By

Yale University

Verification Date

November 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP