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
  Purpose

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

Resource links provided by NLM:


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
1
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.


  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00762242

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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
ClinicalTrials.gov 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:
metabolomics
flow-mediated vasodilation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014