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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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ClinicalTrials.gov Identifier: NCT01609088
Recruitment Status : Completed
First Posted : May 31, 2012
Last Update Posted : July 24, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Type 2 Diabetes Mellitus Dietary Supplement: Erythritol-containing beverage

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pilot Study of the Effects of Erythritol on Endothelial Function in Patients With Type 2 Diabetes Mellitus
Study Start Date : May 2012
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Erythritol-containing beverage Dietary Supplement: Erythritol-containing beverage
Orange flavored beverage containing erythritol


Outcome Measures

Primary Outcome Measures :
  1. Brachial artery flow mediated dilation [ Time Frame: Change from baseline at 28 days ]

Secondary Outcome Measures :
  1. Brachial artery flow-mediated dilation [ Time Frame: Change from baseline at 2 hours ]
    Reactive hyperemia, carotid femoral pulse wave velocity, fingertip tonometry.

  2. Reactive hyperemia [ Time Frame: Change from baseline at 2 hours and 28 days ]
  3. Carotid femoral pulse wave velocity [ Time Frame: Change from baseline at 28 days ]
  4. Fingertip tonometry [ Time Frame: Change from baseline at 2 hours and 28 days ]
  5. Urine F2 isoprostanes [ Time Frame: Change from baseline at 28 days ]
  6. C-reactive protein [ Time Frame: Change from baseline at 28 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609088


Locations
United States, Massachusetts
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Cargill
Investigators
Principal Investigator: Joseph A. Vita, MD Boston University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joseph A. Vita, Professor of Medicine, Boston University
ClinicalTrials.gov Identifier: NCT01609088     History of Changes
Other Study ID Numbers: H-31447
First Posted: May 31, 2012    Key Record Dates
Last Update Posted: July 24, 2013
Last Verified: July 2013

Keywords provided by Joseph A. Vita, Boston University:
endothelium
diabetes mellitus
oxidative stress

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Erythritol
Vasodilator Agents