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Metabolomic Profiling of Novel Mediators of Vascular Function

This study has been terminated.
(Study enrollment was no adequate.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00762242
First Posted: September 30, 2008
Last Update Posted: December 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Joshua A. Beckman, MD, Brigham and Women's Hospital
September 26, 2008
September 30, 2008
December 12, 2016
May 2007
February 2018   (Final data collection date for primary outcome measure)
change from baseline (pre-forearm ischemia) in circulating metabolites compared with post-ischemic forearm measurements [ Time Frame: pre/post 5 minute ischemic stimulus ]
Same as current
Complete list of historical versions of study NCT00762242 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Metabolomic Profiling of Novel Mediators of Vascular Function
Metabolomic Profiling of Novel Mediators of Vascular Function
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.
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
plasma samples for assays of novel biomarkers
Non-Probability Sample
community sample
Type 2 Diabetes Mellitus
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.

1
Blood sampling and brachial artery ultrasound
Intervention: Procedure: blood sampling and brachial artery ultrasound
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
48
February 2018
February 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00762242
2007P-000669
Yes
Not Provided
Not Provided
Joshua A. Beckman, MD, Brigham and Women's Hospital
Brigham and Women's Hospital
Not Provided
Principal Investigator: Joshua A. Beckman, M.D. Brigham and Women's Hospital
Brigham and Women's Hospital
December 2016