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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Erythritol-containing beverage
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes Mellitus focused on measuring endothelium, diabetes mellitus, oxidative stress

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Erythritol-containing beverage

Arm Description

Outcomes

Primary Outcome Measures

Brachial artery flow mediated dilation

Secondary Outcome Measures

Brachial artery flow-mediated dilation
Reactive hyperemia, carotid femoral pulse wave velocity, fingertip tonometry.
Reactive hyperemia
Carotid femoral pulse wave velocity
Fingertip tonometry
Urine F2 isoprostanes
C-reactive protein

Full Information

First Posted
May 25, 2012
Last Updated
July 23, 2013
Sponsor
Boston University
Collaborators
Cargill
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1. Study Identification

Unique Protocol Identification Number
NCT01609088
Brief Title
Pilot Study of the Effects of Erythritol on Endothelial Function in Patients With Type 2 Diabetes Mellitus
Official Title
Pilot Study of the Effects of Erythritol on Endothelial Function in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston University
Collaborators
Cargill

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
endothelium, diabetes mellitus, oxidative stress

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erythritol-containing beverage
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Erythritol-containing beverage
Intervention Description
Orange flavored beverage containing erythritol
Primary Outcome Measure Information:
Title
Brachial artery flow mediated dilation
Time Frame
Change from baseline at 28 days
Secondary Outcome Measure Information:
Title
Brachial artery flow-mediated dilation
Description
Reactive hyperemia, carotid femoral pulse wave velocity, fingertip tonometry.
Time Frame
Change from baseline at 2 hours
Title
Reactive hyperemia
Time Frame
Change from baseline at 2 hours and 28 days
Title
Carotid femoral pulse wave velocity
Time Frame
Change from baseline at 28 days
Title
Fingertip tonometry
Time Frame
Change from baseline at 2 hours and 28 days
Title
Urine F2 isoprostanes
Time Frame
Change from baseline at 28 days
Title
C-reactive protein
Time Frame
Change from baseline at 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph A. Vita, MD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24366423
Citation
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.
Results Reference
derived

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

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