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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01609088
• Other study ID #: H-31447
• Status: Completed
• Phase: N/A
• First received: May 25, 2012
• Last updated: July 23, 2013
• Start date: May 2012
• Est. completion date: December 2012

Study information

• Verified date: July 2013
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 65 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• Erythritol-containing beverage
Orange flavored beverage containing erythritol

Locations

Country	Name	City	State
United States	Boston University School of Medicine	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	Cargill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brachial artery flow mediated dilation		Change from baseline at 28 days	No
Secondary	Brachial artery flow-mediated dilation	Reactive hyperemia, carotid femoral pulse wave velocity, fingertip tonometry.	Change from baseline at 2 hours	No
Secondary	Reactive hyperemia		Change from baseline at 2 hours and 28 days	No
Secondary	Carotid femoral pulse wave velocity		Change from baseline at 28 days	No
Secondary	Fingertip tonometry		Change from baseline at 2 hours and 28 days	No
Secondary	Urine F2 isoprostanes		Change from baseline at 28 days	No
Secondary	C-reactive protein		Change from baseline at 28 days	No