Metabolomic Profiling of Novel Mediators of Vascular Function

NCT ID: NCT00762242

Last Updated: 2016-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2018-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Keywords

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metabolomics flow-mediated vasodilation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Blood sampling and brachial artery ultrasound

blood sampling and brachial artery ultrasound

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Joshua A. Beckman, MD

Associate Professor of Medicine, Harvard Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joshua A. Beckman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2007P-000669

Identifier Type: -

Identifier Source: org_study_id