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
  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: Double Blind (Subject, Caregiver, 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 Brigham and Women's Hospital:

Primary Outcome Measures:
  • Functional transcranial doppler measures [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 25
Study Start Date: April 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (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

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Naomi DL Fisher, MD, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01482247     History of Changes
Other Study ID Numbers: NCT008957003
Study First Received: November 28, 2011
Last Updated: March 25, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014