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Sioux Falls, South Dakota 57105


Purpose:

The purpose of this clinical research study is to evaluate the effects an investigational food product has on the blood sugar and insulin levels in individuals with diabetes.


Study summary:

The investigational product has helped decrease the amount of insulin needed in treating diabetic dogs and has improved the dogs' longevity and quality of life. Observational analysis by trained veterinarians has indicated that the natural fluctuations in blood glucose levels do not exist in dogs consuming the product. An initial Phase 1 study tested the product in a brownie form. The product has been reformulated to capsule form for the Phase 2 study. The hypothesis for this study is that diabetic individuals will decrease their insulin/diabetic medication usage and have a decrease in glucose levels after consuming the product for 16 weeks.


Criteria:

Inclusion Criteria: - Men and women who are at least 18 years old - Diagnosis of Type 2 Diabetes - Has been on stable diabetes medication/insulin for the past three months Exclusion Criteria: - Women who are pregnant, breastfeeding or planning to become pregnant - Diagnosis of Celiac Disease or gluten intolerance - Current or active kidney disease - Current or active liver disease - Any food allergies


NCT ID:

NCT01275027


Primary Contact:

Principal Investigator
Edward Zawada, MD
Avera McKennan Hospital & University Health Center


Backup Contact:

N/A


Location Contact:

Sioux Falls, South Dakota 57105
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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