Pilot Study of the Effects of Erythritol on Endothelial Function in Patients With Type 2 Diabetes Mellitus

July 23, 2013 updated by: Joseph A. Vita, Boston University
The study will determine whether acute and chronic consumption of a beverage containing erythritol will improve endothelial function in patients with type 2 diabetes mellitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes mellitus
  • Otherwise healthy

Exclusion Criteria:

  • Pregnant
  • BMI>35 kg/m2
  • Long acting insulin treatment
  • Other major illness, drug abuse
  • Treatment with an investigational drug within 12 weeks
  • Treatment with dietary or vitamin supplements
  • Smoking within 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Erythritol-containing beverage
Dietary supplement: Erythritol-containing beverage
Orange flavored beverage containing erythritol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Brachial artery flow mediated dilation
Time Frame: Change from baseline at 28 days
Change from baseline at 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brachial artery flow-mediated dilation
Time Frame: Change from baseline at 2 hours
Reactive hyperemia, carotid femoral pulse wave velocity, fingertip tonometry.
Change from baseline at 2 hours
Reactive hyperemia
Time Frame: Change from baseline at 2 hours and 28 days
Change from baseline at 2 hours and 28 days
Carotid femoral pulse wave velocity
Time Frame: Change from baseline at 28 days
Change from baseline at 28 days
Fingertip tonometry
Time Frame: Change from baseline at 2 hours and 28 days
Change from baseline at 2 hours and 28 days
Urine F2 isoprostanes
Time Frame: Change from baseline at 28 days
Change from baseline at 28 days
C-reactive protein
Time Frame: Change from baseline at 28 days
Change from baseline at 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University

Collaborators

Cargill

Investigators

  • Principal Investigator: Joseph A. Vita, MD, Boston University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

May 25, 2012

First Submitted That Met QC Criteria

May 29, 2012

First Posted (ESTIMATE)

May 31, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 24, 2013

Last Update Submitted That Met QC Criteria

July 23, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-31447

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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