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

Not Applicable
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Dietary Supplement: Erythritol-containing beverage
Registration Number
NCT01609088
Lead Sponsor
Boston University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
24
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Erythritol-containing beverageErythritol-containing beverage-
Primary Outcome Measures
NameTimeMethod
Brachial artery flow mediated dilationChange from baseline at 28 days
Secondary Outcome Measures
NameTimeMethod
Brachial artery flow-mediated dilationChange from baseline at 2 hours

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

Reactive hyperemiaChange from baseline at 2 hours and 28 days
Carotid femoral pulse wave velocityChange from baseline at 28 days
Fingertip tonometryChange from baseline at 2 hours and 28 days
Urine F2 isoprostanesChange from baseline at 28 days
C-reactive proteinChange from baseline at 28 days

Trial Locations

Locations (1)

Boston University School of Medicine

🇺🇸

Boston, Massachusetts, United States

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