Metabolomic Profiling of Novel Mediators of Vascular Function
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ClinicalTrials.gov Identifier: NCT00762242 |
Recruitment Status
:
Terminated
(Study enrollment was no adequate.)
First Posted
: September 30, 2008
Last Update Posted
: December 12, 2016
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Tracking Information | ||||
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First Submitted Date | September 26, 2008 | |||
First Posted Date | September 30, 2008 | |||
Last Update Posted Date | December 12, 2016 | |||
Study Start Date | May 2007 | |||
Estimated Primary Completion Date | February 2018 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
change from baseline (pre-forearm ischemia) in circulating metabolites compared with post-ischemic forearm measurements [ Time Frame: pre/post 5 minute ischemic stimulus ] | |||
Original Primary Outcome Measures | Same as current | |||
Change History | Complete list of historical versions of study NCT00762242 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures | Not Provided | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Metabolomic Profiling of Novel Mediators of Vascular Function | |||
Official Title | 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 | Observational | |||
Study Design | Observational Model: Case Control Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples Without DNA Description: plasma samples for assays of novel biomarkers |
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Sampling Method | Non-Probability Sample | |||
Study Population | community sample | |||
Condition | Type 2 Diabetes Mellitus | |||
Intervention | 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. |
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Study Groups/Cohorts | 1
Blood sampling and brachial artery ultrasound
Intervention: Procedure: blood sampling and brachial artery ultrasound |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Terminated | |||
Actual Enrollment |
48 | |||
Original Estimated Enrollment |
80 | |||
Estimated Study Completion Date | February 2018 | |||
Estimated Primary Completion Date | February 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00762242 | |||
Other Study ID Numbers | 2007P-000669 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Joshua A. Beckman, MD, Brigham and Women's Hospital | |||
Study Sponsor | Brigham and Women's Hospital | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Brigham and Women's Hospital | |||
Verification Date | December 2016 |