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Metabolomic Profiling of Novel Mediators of Vascular Function

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ClinicalTrials.gov Identifier: NCT00762242
Recruitment Status : Terminated (Study enrollment was no adequate.)
First Posted : September 30, 2008
Last Update Posted : December 12, 2016
Sponsor:
Information provided by (Responsible Party):
Joshua A. Beckman, MD, Brigham and Women's Hospital

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Type 2 Diabetes Mellitus Procedure: blood sampling and brachial artery ultrasound

Study Design
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Study Type : Observational
Actual Enrollment : 48 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Metabolomic Profiling of Novel Mediators of Vascular Function
Study Start Date : May 2007
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

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U.S. FDA Resources

Groups and Cohorts
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Group/Cohort Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. change from baseline (pre-forearm ischemia) in circulating metabolites compared with post-ischemic forearm measurements [ Time Frame: pre/post 5 minute ischemic stimulus ]

Biospecimen Retention:   Samples Without DNA
plasma samples for assays of novel biomarkers

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: September 30, 2008    Key Record Dates
Last Update Posted: December 12, 2016
Last Verified: December 2016

Keywords provided by Joshua A. Beckman, MD, 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