L-Arginine, Vascular Response and Mechanisms

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Naomi DL Fisher, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01482247
First received: November 28, 2011
Last updated: March 25, 2014
Last verified: March 2014

November 28, 2011
March 25, 2014
April 2012
August 2013   (final data collection date for primary outcome measure)
Functional transcranial doppler measures [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01482247 on ClinicalTrials.gov Archive Site
  • Flow Mediated Dilation (FMD) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Finger Blood Flow - Plethysmography (PAT) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
L-Arginine, Vascular Response and Mechanisms
L-Arginine, Vascular Response and Mechanisms

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Hypertension
  • Diabetes
  • Dietary Supplement: L-Arginine
    Dietary Supplement
  • Dietary Supplement: Placebo Supplement
    Dietary Supplement
  • Active Comparator: L-arginine
    Intervention: Dietary Supplement: L-Arginine
  • Placebo Comparator: Placebo Supplement
    Intervention: Dietary Supplement: Placebo Supplement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
August 2013
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • diabetes and/or hypertension

Exclusion Criteria:

  • alzheimers disease, dementia, stroke, active herpes, recent angina or heart attack
Both
70 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01482247
NCT008957003
No
Naomi DL Fisher, MD, Brigham and Women's Hospital
Brigham and Women's Hospital
Not Provided
Principal Investigator: Naomi Fisher, MD Brigham and Women's Hospital
Brigham and Women's Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP