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

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. |
- 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

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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 |
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

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
United States, Massachusetts | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Joshua A. Beckman, M.D. | Brigham and Women's Hospital |
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 |