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

This study has been completed.
Sponsor:
Collaborator:
Cargill
Information provided by (Responsible Party):
Joseph A. Vita, Boston University
ClinicalTrials.gov Identifier:
NCT01609088
First received: May 25, 2012
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

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 Intervention
Type 2 Diabetes Mellitus
Dietary Supplement: Erythritol-containing beverage

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Brachial artery flow mediated dilation [ Time Frame: Change from baseline at 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Brachial artery flow-mediated dilation [ Time Frame: Change from baseline at 2 hours ] [ Designated as safety issue: No ]
    Reactive hyperemia, carotid femoral pulse wave velocity, fingertip tonometry.

  • Reactive hyperemia [ Time Frame: Change from baseline at 2 hours and 28 days ] [ Designated as safety issue: No ]
  • Carotid femoral pulse wave velocity [ Time Frame: Change from baseline at 28 days ] [ Designated as safety issue: No ]
  • Fingertip tonometry [ Time Frame: Change from baseline at 2 hours and 28 days ] [ Designated as safety issue: No ]
  • Urine F2 isoprostanes [ Time Frame: Change from baseline at 28 days ] [ Designated as safety issue: No ]
  • C-reactive protein [ Time Frame: Change from baseline at 28 days ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: May 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erythritol-containing beverage Dietary Supplement: Erythritol-containing beverage
Orange flavored beverage containing erythritol

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Joseph A. Vita, Professor of Medicine, Boston University
ClinicalTrials.gov Identifier: NCT01609088     History of Changes
Other Study ID Numbers: H-31447
Study First Received: May 25, 2012
Last Updated: July 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 25, 2014