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Sponsored by: |
Duke University |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00585897 |
Purpose The purpose of this study is to investigate the effects of discontinuation of sugar sweetened beverages on hemoglobin A1c (HbA1c) and plasma fasting and post-prandial blood glucose in a population with type 2 diabetes.
Hypothesis Elimination of sugar sweetened beverages from the diet for a 4 week period will lead to a decrease in HbA1c and plasma fasting and 2 hour post prandial blood glucose in a population with a history of type 2 diabetes and high consumption of sugar sweetened beverages.
Specific aims to test hypothesis
Condition | Intervention |
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Type 2 Diabetes Obesity |
Behavioral: discontinuation of sugar sweetened beverages |
Study Type: | Interventional |
Study Design: | Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Title: Effects of Discontinuation of Sugar Sweetened Beverages on Hemoglobin A1c, Fasting and Post Prandial Blood Glucose in Type 2 Diabetics |
Enrollment: | 5 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Type and Design of Study This will be a pilot study including adult patients age >/= 18 diagnosed with Type 2 Diabetes who are patients at the Duke Outpatient Clinic (DOC) or patients in the general medicine or family practice clinics in Durham County. The intervention will be elimination of sugar sweetened beverages from the diet in a population of type 2 diabetic subjects for four weeks. Sugar sweetened beverages will be defined as any liquid beverage containing calories that can be attributed to natural or added sugar. This will not include beverages that contain mainly artificial sweeteners (e.g.: NutraSweet®, saccharin, Splenda®, or Equal®), plain milk, or water.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Prior diagnosis of Type 2 Diabetes for at least 1 year based on one of the following:
Exclusion Criteria:
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | Bryan C. Batch, M.D. | Duke University |
Responsible Party: | Duke University Medical Center ( Bryan C. Batch, M.D. ) |
Study ID Numbers: | 8741-06 |
Study First Received: | December 21, 2007 |
Last Updated: | January 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00585897 |
Health Authority: | United States: Institutional Review Board |
Diabetes Obesity |
Obesity Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Overweight Body Weight Signs and Symptoms |
Diabetes Mellitus, Type 2 Nutrition Disorders Overnutrition Endocrinopathy Glucose Metabolism Disorders Metabolic disorder |