Metabolomic Profiling of Novel Mediators of Vascular Function

Tracking Information
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; (submitted: September 29, 2008)	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
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	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.
Study Groups/Cohorts	1; 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	Terminated
Actual Enrollment; (submitted: August 15, 2013)	48
Original Estimated Enrollment; (submitted: September 29, 2008)	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: 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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
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	Principal Investigator: Joshua A. Beckman, M.D. Brigham and Women's Hospital
PRS Account	Brigham and Women's Hospital
Verification Date	December 2016