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Dose-Dependent Effects of Erythritol on Endothelial Function in Type 2 Diabetes Mellitus

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Erythritol

About this trial

This is an interventional basic science trial for Type 2 Diabetes Mellitus focused on measuring Erythritol, Endothelial function

Eligibility Criteria

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

Inclusion Criteria:

Male and Female subjects
Otherwise healthy patients with Type 2 diabetes mellitus as defined by fasting blood glucose >125 mg/dl or with ongoing treatment for Type 2 diabetes mellitus with the exception of insulin.

Exclusion Criteria:

Women with a positive urine pregnancy test
Body mass index >35 kg/m2
Current daily long-acting insulin therapy (short acting, insulin as needed is not an exclusion).
Clinical history of other major illness including cancer, renal failure, hepatic failure, or other conditions that in the judgment of the principal investigator make a clinical study inappropriate.
Treatment with an investigational drug within the last twelve weeks
History of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
Treatment with vitamin E, vitamin C, and beta carotene, lipoic acid, and other food or herbal supplements within 1 month of enrollment. Subjects taking multivitamins or other forms of vitamin E and C in doses that do not exceed two times the recommended daily allowance will not be excluded.
Recent change in diet or level of physical activity that in the judgment of the investigators would be likely to affect endothelial function (to be evaluated on a case by case basis).
Ongoing illicit drug use or alcohol abuse.
Sensitivity/intolerance to dietary polyols.

Sites / Locations

Boston University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Erythritol

Arm Description

Orange-flavored beverage containing 6, 12, or 18 grams of erythritol

Outcomes

Primary Outcome Measures

Endothelial function

Change in pulse amplitude in the fingertip in response to reactive hyperemia measured by peripheral arterial tonometry.

Secondary Outcome Measures

Full Information

NCT ID

NCT01908348

First Posted

July 23, 2013

Last Updated

February 27, 2018

Sponsor

Boston University

Collaborators

Cargill

1. Study Identification

Unique Protocol Identification Number

NCT01908348

Brief Title

Dose-Dependent Effects of Erythritol on Endothelial Function in Type 2 Diabetes Mellitus

Official Title

Pilot Study: Dose Dependent Effects of Erythritol on Endothelial Function in Patients With Type 2 Diabetes Mellitus

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

July 18, 2013 (Actual)

Primary Completion Date

December 1, 2014 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boston University

Collaborators

Cargill

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study is an open-label pilot designed to examine the dose-dependent effects of erythritol, a zero calorie sweetener, on endothelial function. Twenty-four subjects with type 2 diabetes mellitus will make three study visits. At each visit, the will consume an orange-flavored beverage containing escalating amounts of erythritol (6, 12, and 18 grams). Endothelial function will be assessed before and two hours after beverage consumption. Endothelial function will be measured as the change in pulse amplitude in response to reactive hyperemia measured in the fingertip by peripheral arterial tonometry. The results will be used to plan a randomized, placebo-controlled study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

Keywords

Erythritol, Endothelial function

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

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Erythritol

Arm Type

Experimental

Arm Description

Orange-flavored beverage containing 6, 12, or 18 grams of erythritol

Intervention Type

Dietary Supplement

Intervention Name(s)

Erythritol

Primary Outcome Measure Information:

Title

Endothelial function

Description

Change in pulse amplitude in the fingertip in response to reactive hyperemia measured by peripheral arterial tonometry.

Time Frame

2 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and Female subjects Otherwise healthy patients with Type 2 diabetes mellitus as defined by fasting blood glucose >125 mg/dl or with ongoing treatment for Type 2 diabetes mellitus with the exception of insulin. Exclusion Criteria: Women with a positive urine pregnancy test Body mass index >35 kg/m2 Current daily long-acting insulin therapy (short acting, insulin as needed is not an exclusion). Clinical history of other major illness including cancer, renal failure, hepatic failure, or other conditions that in the judgment of the principal investigator make a clinical study inappropriate. Treatment with an investigational drug within the last twelve weeks History of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study. Treatment with vitamin E, vitamin C, and beta carotene, lipoic acid, and other food or herbal supplements within 1 month of enrollment. Subjects taking multivitamins or other forms of vitamin E and C in doses that do not exceed two times the recommended daily allowance will not be excluded. Recent change in diet or level of physical activity that in the judgment of the investigators would be likely to affect endothelial function (to be evaluated on a case by case basis). Ongoing illicit drug use or alcohol abuse. Sensitivity/intolerance to dietary polyols.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Naomi M Hamburg, 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

Plan to Share IPD

Learn more about this trial

Dose-Dependent Effects of Erythritol on Endothelial Function in Type 2 Diabetes Mellitus

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