Dose-Dependent Effects of Erythritol on Endothelial Function in Type 2 Diabetes Mellitus

Inclusion criteria

• 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 criteria

• 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.