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Metabolomic Profiling of Novel Mediators of Vascular Function
This study has been terminated.
(Study enrollment was no adequate.)
Sponsor:
Brigham and Women's Hospital
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: December 8, 2016
Last verified: December 2016
| Tracking Information | ||||
|---|---|---|---|---|
| First Received Date ICMJE | September 26, 2008 | |||
| Last Updated Date | December 8, 2016 | |||
| Start Date ICMJE | May 2007 | |||
| Estimated Primary Completion Date | February 2018 (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 ] | |||
| 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 |
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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 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. |
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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 | |||
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* 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 ICMJE | Terminated | |||
| Enrollment ICMJE | 48 | |||
| Estimated Completion Date | February 2018 | |||
| Estimated Primary Completion Date | February 2018 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | 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 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 | |||
| 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 ICMJE | Brigham and Women's Hospital | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | Brigham and Women's Hospital | |||
| Verification Date | December 2016 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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