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

NCT ID: NCT01609088

Last Updated: 2013-07-24

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

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Erythritol-containing beverage

Group Type EXPERIMENTAL

Erythritol-containing beverage

Intervention Type DIETARY_SUPPLEMENT

Orange flavored beverage containing erythritol

Interventions

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Erythritol-containing beverage

Orange flavored beverage containing erythritol

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cargill

INDUSTRY

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role lead

Responsible Party

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Joseph A. Vita

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph A. Vita, MD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

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Boston University School of Medicine

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Flint N, Hamburg NM, Holbrook M, Dorsey PG, LeLeiko RM, Berger A, de Cock P, Bosscher D, Vita JA. Effects of erythritol on endothelial function in patients with type 2 diabetes mellitus: a pilot study. Acta Diabetol. 2014;51(3):513-6. doi: 10.1007/s00592-013-0534-2. Epub 2013 Dec 24.

Reference Type DERIVED
PMID: 24366423 (View on PubMed)

Other Identifiers

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H-31447

Identifier Type: -

Identifier Source: org_study_id

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