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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014