L-Arginine, Vascular Response and Mechanisms

NCT ID: NCT01482247

Last Updated: 2016-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-01-31

Brief Summary

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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).

Detailed Description

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Conditions

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Hypertension Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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L-arginine

Group Type ACTIVE_COMPARATOR

L-Arginine

Intervention Type DIETARY_SUPPLEMENT

Dietary Supplement

Placebo Supplement

Group Type PLACEBO_COMPARATOR

Placebo Supplement

Intervention Type DIETARY_SUPPLEMENT

Dietary Supplement

Interventions

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L-Arginine

Dietary Supplement

Intervention Type DIETARY_SUPPLEMENT

Placebo Supplement

Dietary Supplement

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* diabetes and/or hypertension

Exclusion Criteria

* alzheimers disease, dementia, stroke, active herpes, recent angina or heart attack
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Naomi DL Fisher, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Naomi Fisher, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2008A052379

Identifier Type: -

Identifier Source: org_study_id

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