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L-Arginine, Vascular Response and Mechanisms

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01482247
First Posted: November 30, 2011
Last Update Posted: July 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Naomi DL Fisher, MD, Brigham and Women's Hospital
  Purpose
The purpose of the study is to employ the supplement L-arginine to test the hypothesis that activation of blood flow to the brain during cognitive tasks is regulated by nitric oxide in older subjects with diabetes mellitus and/or hypertension (high blood pressure).

Condition Intervention Phase
Hypertension Diabetes Dietary Supplement: L-Arginine Dietary Supplement: Placebo Supplement Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: L-Arginine, Vascular Response and Mechanisms

Resource links provided by NLM:


Further study details as provided by Naomi DL Fisher, MD, Brigham and Women's Hospital:

Primary Outcome Measures:
  • Functional transcranial doppler measures [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Flow Mediated Dilation (FMD) [ Time Frame: 6 weeks ]
  • Finger Blood Flow - Plethysmography (PAT) [ Time Frame: 6 weeks ]

Enrollment: 25
Study Start Date: April 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: L-arginine Dietary Supplement: L-Arginine
Dietary Supplement
Placebo Comparator: Placebo Supplement Dietary Supplement: Placebo Supplement
Dietary Supplement

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diabetes and/or hypertension

Exclusion Criteria:

  • alzheimers disease, dementia, stroke, active herpes, recent angina or heart attack
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01482247


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: Naomi Fisher, MD Brigham and Women's Hospital
  More Information

Responsible Party: Naomi DL Fisher, MD, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01482247     History of Changes
Other Study ID Numbers: 2008A052379
First Submitted: November 28, 2011
First Posted: November 30, 2011
Last Update Posted: July 28, 2016
Last Verified: July 2016