Microvascular Reactivity. | NCT00259701

Studies
Microvascular Reactivity.

NCT00259701

Sponsor

Yale University

Status

Completed

Last Update Posted

Oct 6, 2006Estimated

Enrollment

Phase

Not provided

Conditions

Diabetes
Retinopathy
Vascular Pathology

Interventions

Laser Doppler Flowmetry with topical acetylcholine and nitroglycerin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Not provided

Completion Date

Sep 2005

First Submitted Date

Nov 28, 2005

First Submission Date that Met QC Criteria

Nov 28, 2005

First Posted Date

Nov 29, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 5, 2006

Last Update Posted Date

Oct 6, 2006Estimated

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Laser Doppler Flowmetry with topical acetylcholine and nitroglycerin	Device

Eligibility Module

Eligibility Criteria

Inclusion Criteria: diabetic. -

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David G Silverman	Yale University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yale School of Medicine		New Haven	Connecticut	06510	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17876370	Derived	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.

ID	Term
D003920	Diabetes Mellitus
D012164	Retinal Diseases
D000783	Aneurysm

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D003935	Diagnostic Techniques, Cardiovascular
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D012212	Rheology