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

Boston University24 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

Erythritol-containing beverageDIETARY_SUPPLEMENT

Orange flavored beverage containing erythritol

Eligibility

Sex: ALLMin age: 35 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Boston University School of Medicine

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Brachial artery flow mediated dilation

Time frame: Change from baseline at 28 days

Secondary Outcomes

Brachial artery flow-mediated dilation

Reactive hyperemia, carotid femoral pulse wave velocity, fingertip tonometry.

Time frame: Change from baseline at 2 hours

Reactive hyperemia

Time frame: Change from baseline at 2 hours and 28 days

Carotid femoral pulse wave velocity

Time frame: Change from baseline at 28 days

Fingertip tonometry

Time frame: Change from baseline at 2 hours and 28 days

Urine F2 isoprostanes

Time frame: Change from baseline at 28 days

C-reactive protein

Time frame: Change from baseline at 28 days

Data from ClinicalTrials.gov

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