Status:
COMPLETED
Dose-Dependent Effects of Erythritol on Endothelial Function in Type 2 Diabetes Mellitus
Lead Sponsor:
Boston University
Collaborating Sponsors:
Cargill
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
35-65 years
Phase:
NA
Brief Summary
This study is an open-label pilot designed to examine the dose-dependent effects of erythritol, a zero calorie sweetener, on endothelial function. Twenty-four subjects with type 2 diabetes mellitus wi...
Eligibility Criteria
Inclusion
- Male and Female subjects
- Otherwise healthy patients with Type 2 diabetes mellitus as defined by fasting blood glucose \>125 mg/dl or with ongoing treatment for Type 2 diabetes mellitus with the exception of insulin.
Exclusion
- Women with a positive urine pregnancy test
- Body mass index \>35 kg/m2
- Current daily long-acting insulin therapy (short acting, insulin as needed is not an exclusion).
- Clinical history of other major illness including cancer, renal failure, hepatic failure, or other conditions that in the judgment of the principal investigator make a clinical study inappropriate.
- Treatment with an investigational drug within the last twelve weeks
- History of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
- Treatment with vitamin E, vitamin C, and beta carotene, lipoic acid, and other food or herbal supplements within 1 month of enrollment. Subjects taking multivitamins or other forms of vitamin E and C in doses that do not exceed two times the recommended daily allowance will not be excluded.
- Recent change in diet or level of physical activity that in the judgment of the investigators would be likely to affect endothelial function (to be evaluated on a case by case basis).
- Ongoing illicit drug use or alcohol abuse.
- Sensitivity/intolerance to dietary polyols.
Key Trial Info
Start Date :
July 18 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01908348
Start Date
July 18 2013
End Date
December 1 2016
Last Update
February 28 2018
Active Locations (1)
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1
Boston University School of Medicine
Boston, Massachusetts, United States, 02118