Skip to main content
OpenTrials
Completed

NCT Number: NCT01609088

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erythritol-containing beverage

Dietary Supplement

Orange flavored beverage containing erythritol

Primary outcomes

  1. Brachial artery flow mediated dilation

    Time frame: Change from baseline at 28 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • Cargill

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 31, 2012
Registry last updated
Jul 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.