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

September 26, 2008
August 15, 2013
May 2007
February 2014   (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 ] [ Designated as safety issue: No ]
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 2014
February 2014   (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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00762242
2007P-000669
Yes
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
August 2013

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