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Metabolomic Profiling of Novel Mediators of Vascular Function

Metabolomic Profiling of Novel Mediators of Vascular Function

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00762242
Enrollment
48
Registered
2008-09-30
Start date
2007-05-31
Completion date
2018-02-28
Last updated
2016-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

metabolomics, flow-mediated vasodilation

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.

Interventions

PROCEDUREblood 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.

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
change from baseline (pre-forearm ischemia) in circulating metabolites compared with post-ischemic forearm measurementspre/post 5 minute ischemic stimulus

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026