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L-Arginine, Vascular Response and Mechanisms

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ClinicalTrials.gov Identifier: NCT01482247
Recruitment Status : Completed
First Posted : November 30, 2011
Last Update Posted : July 28, 2016
Sponsor:
Information provided by (Responsible Party):
Naomi DL Fisher, MD, Brigham and Women's Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Diabetes Dietary Supplement: L-Arginine Dietary Supplement: Placebo Supplement Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
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
Study Start Date : April 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: L-arginine Dietary Supplement: L-Arginine
Dietary Supplement
Placebo Comparator: Placebo Supplement Dietary Supplement: Placebo Supplement
Dietary Supplement



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

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


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

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

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 Posted: November 30, 2011    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016