Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Cargill
Information provided by (Responsible Party):
Joseph A. Vita, Boston University
ClinicalTrials.gov Identifier:
NCT01609088
First received: May 25, 2012
Last updated: December 6, 2012
Last verified: December 2012
History of Changes
  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:

Drug Information available for: Erythritol
U.S. FDA Resources

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 ]

Estimated Enrollment: 24
Study Start Date: May 2012
Estimated Study Completion Date: December 2012
Estimated 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
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: December 6, 2012
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 May 16, 2013