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Metabolomic Profiling of Novel Mediators of Vascular Function

This study has been terminated.
(Study enrollment was no adequate.)
Information provided by (Responsible Party):
Joshua A. Beckman, MD, Brigham and Women's Hospital Identifier:
First received: September 26, 2008
Last updated: August 15, 2013
Last verified: August 2013

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.

Condition Intervention
Type 2 Diabetes Mellitus
Procedure: blood sampling and brachial artery ultrasound

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Metabolomic Profiling of Novel Mediators of Vascular Function

Further study details as provided by Brigham and Women's Hospital:

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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

plasma samples for assays of novel biomarkers

Enrollment: 48
Study Start Date: May 2007
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Blood sampling and brachial artery ultrasound
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

community sample


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00762242

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Principal Investigator: Joshua A. Beckman, M.D. Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Joshua A. Beckman, MD, Associate Professor of Medicine, Harvard Medical School, Brigham and Women's Hospital Identifier: NCT00762242     History of Changes
Other Study ID Numbers: 2007P-000669
Study First Received: September 26, 2008
Last Updated: August 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
flow-mediated vasodilation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases processed this record on March 01, 2015