Dose-Dependent Effects of Erythritol on Endothelial Function in Type 2 Diabetes Mellitus
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 35 - 65 |
| Updated: | 5/5/2014 |
| Start Date: | July 2013 |
| End Date: | March 2014 |
| Contact: | Monika Holbrook, MS |
| Email: | mholbro@bu.edu |
Pilot Study: Dose Dependent Effects of Erythritol on Endothelial Function in Patients With Type 2 Diabetes Mellitus
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 will make three study visits. At each visit, the will consume an
orange-flavored beverage containing escalating amounts of erythritol (6, 12, and 18 grams).
Endothelial function will be assessed before and two hours after beverage consumption.
Endothelial function will be measured as the change in pulse amplitude in response to
reactive hyperemia measured in the fingertip by peripheral arterial tonometry. The results
will be used to plan a randomized, placebo-controlled study.
erythritol, a zero calorie sweetener, on endothelial function. Twenty-four subjects with
type 2 diabetes mellitus will make three study visits. At each visit, the will consume an
orange-flavored beverage containing escalating amounts of erythritol (6, 12, and 18 grams).
Endothelial function will be assessed before and two hours after beverage consumption.
Endothelial function will be measured as the change in pulse amplitude in response to
reactive hyperemia measured in the fingertip by peripheral arterial tonometry. The results
will be used to plan a randomized, placebo-controlled study.
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.
We found this trial at
1
site
72 East Concord Street
Boston, Massachusetts 02118
Boston, Massachusetts 02118
(617) 638-5300
Boston University School of Medicine A leader in medical education and research, Boston University School...
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