Metabolomic Profiling of Novel Mediators of Vascular Function
This study has been terminated.
(Study enrollment was no adequate.)
Sponsor:
Brigham and Women's Hospital
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
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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 |
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 (Adult, Senior) |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00762242
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
| 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 September 23, 2016