NCT01482247

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2 hypertension

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

July 28, 2016

Status Verified

July 1, 2016

Enrollment Period

1.8 years

First QC Date

November 28, 2011

Last Update Submit

July 27, 2016

Conditions

HypertensionDiabetes

Outcome Measures

Primary Outcomes (1)

  • Functional transcranial doppler measures

    6 weeks

Secondary Outcomes (2)

  • Flow Mediated Dilation (FMD)

    6 weeks

  • Finger Blood Flow - Plethysmography (PAT)

    6 weeks

Study Arms (2)

L-arginine

ACTIVE COMPARATOR
Dietary Supplement: L-Arginine

Placebo Supplement

PLACEBO COMPARATOR
Dietary Supplement: Placebo Supplement

Interventions

L-ArginineDIETARY_SUPPLEMENT

Dietary Supplement

L-arginine
Placebo SupplementDIETARY_SUPPLEMENT

Dietary Supplement

Placebo Supplement

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • diabetes and/or hypertension

You may not qualify if:

  • alzheimers disease, dementia, stroke, active herpes, recent angina or heart attack

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

HypertensionDiabetes Mellitus

Interventions

Arginine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Essential

Study Officials

  • Naomi Fisher, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 28, 2011

First Posted

November 30, 2011

Study Start

April 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

July 28, 2016

Record last verified: 2016-07

Locations

US(1)