Title: Effects of Discontinuation of Sugar Sweetened Beverages on Hemoglobin A1c, Fasting and Post Prandial Blood Glucose in Type 2 Diabetics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Hemoglobin A1c
研究概览
简要总结
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
- Investigate how elimination of sugar sweetened beverages from the diet affects HbA1c and plasma fasting and two hour post prandial blood glucose.
- Test the feasibility of carrying out a simple diet intervention in an outpatient population with type 2 diabetes.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior diagnosis of Type 2 Diabetes for at least 1 year based on one of the following:
- •Fasting blood glucose >126 on two separate occasions
- •Random blood glucose >200 with symptoms
- •Abnormal 75 or 100 gram Oral Glucose Tolerance Test (OGTT) defined as: fasting blood glucose >100, 2hour post prandial blood sugar of >140
- •On medications for diabetes (oral or insulin)
- •Stable but uncontrolled blood glucose (Hemoglobin A1C >7%, </= 12%)
- •Ingestion of at least three eight ounce servings of sugar sweetened beverage daily.
- •Stable solid diet and exercise pattern and agreement not to change these during the study
- •Able and willing to maintain a complete diet diary for three days each week of the study (total of 12 days of recording)
- •Able to attend regular study visits
- •Able to give informed consent
- •Working phone number in order to contact patient
- •Able and willing to understand and comply with the intervention
排除标准
- •Women who are known to be pregnant at enrollment based on a positive pregnancy test. Pregnancy test will be given to all female subjects of child bearing age prior to enrollment in the study. Pregnant women will be excluded on the basis that blood glucose data are significantly affected by the physiology of pregnancy. This exclusion is not based on any potential risk to the pregnant women or fetus.
- •Individuals <18 years of age
- •Diagnosis of Type 1 Diabetes
- •Malabsorbtive syndrome of any type (will be determined based on medical history from patient and/or medical chart)
- •On Acarbose prior to start of study
- •On a weight loss diet within one month of enrollment
结局指标
主要结局
Hemoglobin A1c
时间窗: 4 weeks for each participant
次要结局
- Fasting glucose(4 weeks)