Metabolomic Profiling of Novel Mediators of Vascular Function

Terminated

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Procedure: blood sampling and brachial artery ultrasound

• Registration Number: NCT00762242
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2008-09-26
• Study First Submitted QC: 2008-09-29
• Study First Posted: 2008-09-30
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-08
• Last Update Posted: 2016-12-12
• Primary Completion: 2018-02
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	blood sampling and brachial artery ultrasound	Blood sampling and brachial artery ultrasound

Primary Outcome Measures

Name	Time	Method
change from baseline (pre-forearm ischemia) in circulating metabolites compared with post-ischemic forearm measurements	pre/post 5 minute ischemic stimulus

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States