Metabolomic Profiling of Novel Mediators of Vascular Function

This study has been terminated.

(Study enrollment was no adequate.)

Sponsor:

Information provided by (Responsible Party):

Joshua A. Beckman, MD, Brigham and Women's Hospital

ClinicalTrials.gov Identifier:

NCT00762242

First received: September 26, 2008

Last updated: August 15, 2013

Last verified: August 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 26, 2008

Last Updated Date

August 15, 2013

Start Date ^ICMJE

May 2007

Estimated Primary Completion Date

February 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

change from baseline (pre-forearm ischemia) in circulating metabolites compared with post-ischemic forearm measurements [ Time Frame: pre/post 5 minute ischemic stimulus ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00762242 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Metabolomic Profiling of Novel Mediators of Vascular Function

Official Title ^ICMJE

Metabolomic Profiling of Novel Mediators of Vascular Function

Brief Summary

The purpose of this study is to identify and characterize specific chemicals and metabolic pathways that change with forearm ischemia. These changes will be compared with forearm blood flow and flow-mediated vasodilation of the brachial artery.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples Without DNA

Description:

plasma samples for assays of novel biomarkers

Sampling Method

Non-Probability Sample

Study Population

community sample

Condition ^ICMJE

Type 2 Diabetes Mellitus

Intervention ^ICMJE

Procedure: blood sampling and brachial artery ultrasound

Intravenous blood sampling will be performed before and 15 seconds, 30 seconds, 1,2,5,10,and 30 minutes following an ischemic stimulus (inflation of a blood pressure cuff to suprasystolic pressure for 5 minutes)

Brachial artery ultrasound imaging will be performed before and 1 minute after a 5 minute ischemic stimulus, to assess endothelium-dependent vasodilation of the brachial artery.

Following completion of blood sampling, an additional "resting" image of the brachial artery will be obtained. Sub-lingual nitroglycerin will be administered, and the artery will be imaged again after 3 minutes, to assess endothelium-independent vasodilation.

Study Group/Cohort (s)

Blood sampling and brachial artery ultrasound

Intervention: Procedure: blood sampling and brachial artery ultrasound

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Estimated Completion Date

February 2014

Estimated Primary Completion Date

February 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Adults age 18 or older
Type 2 diabetes mellitus

Exclusion Criteria:

Type 1 diabetes mellitus
Type 2 diabetics taking insulin, thiazolidinediones (rosiglitazone or pioglitazone), an amylin analog (Symlin [pramlintide]), or incretin mimetics (Byetta [exenatide])
Pregnancy
Uncontrolled hypertension, > 180/100 mmHg

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00762242

Other Study ID Numbers ^ICMJE

2007P-000669

Has Data Monitoring Committee

Yes

Responsible Party

Joshua A. Beckman, MD, Brigham and Women's Hospital

Study Sponsor ^ICMJE

Brigham and Women's Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Joshua A. Beckman, M.D.

Brigham and Women's Hospital

Information Provided By

Brigham and Women's Hospital

Verification Date

August 2013

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

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