Back to resultsL-Arginine, Vascular Response and Mechanisms
Primary Purpose
Hypertension, Diabetes
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
L-Arginine
Placebo Supplement
Sponsored by
About this trial
This is an interventional prevention trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- diabetes and/or hypertension
Exclusion Criteria:
- alzheimers disease, dementia, stroke, active herpes, recent angina or heart attack
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
L-arginine
Placebo Supplement
Arm Description
Outcomes
Primary Outcome Measures
Functional transcranial doppler measures
Secondary Outcome Measures
Flow Mediated Dilation (FMD)
Finger Blood Flow - Plethysmography (PAT)
Full Information
NCT ID
NCT01482247
First Posted
November 28, 2011
Last Updated
July 27, 2016
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01482247
Brief Title
L-Arginine, Vascular Response and Mechanisms
Official Title
L-Arginine, Vascular Response and Mechanisms
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
L-arginine
Arm Type
Active Comparator
Arm Title
Placebo Supplement
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
L-Arginine
Intervention Description
Dietary Supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Supplement
Intervention Description
Dietary Supplement
Primary Outcome Measure Information:
Title
Functional transcranial doppler measures
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Flow Mediated Dilation (FMD)
Time Frame
6 weeks
Title
Finger Blood Flow - Plethysmography (PAT)
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diabetes and/or hypertension
Exclusion Criteria:
alzheimers disease, dementia, stroke, active herpes, recent angina or heart attack
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naomi Fisher, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
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L-Arginine, Vascular Response and Mechanisms
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