Almond Butter and Fasting Glucose in Adults With Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Fasting Glucose Measured Using Continuous Glucose Monitoring
研究概览
简要总结
A two-period randomized crossover study will be conducted to determine the effect of almond butter as an evening snack on fasting blood glucose in adults with type 2 diabetes, not taking insulin.
详细描述
Control of fasting blood glucose is a challenge for many individuals with diabetes. Researchers want to better understand how a nighttime snack can affect morning fasting blood glucose. A two-period randomized crossover trial will be conducted. Participants will be randomized to receive each treatment for 1 week. During the almond butter treatment, participants will consume 2 tbsp of almond butter per day as an evening snack. The control treatments will be a no-snack control. Fasting blood glucose, as well as glucose trends, will be measured using Continuous Glucose Monitor (CGM). Participants will also be asked to take simple cognitive tests on a study-provided smartphone each day of the study and report their daily food intake and physical activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with diagnosed type 2 diabetes
- •Not on insulin therapy
- •On stable does of oral antihyperglycemic agent (no dose change for 6 months)
- •Currently monitoring blood glucose at home via glucometer
- •Willing and able to adhere to study protocol
排除标准
- •Individuals with type 1 diabetes, cardiovascular disease, kidney disease, liver disease, cancer or inflammatory conditions (e.g. GI disorders, rheumatoid arthritis)
- •Women who are pregnant, breastfeeding, or have been pregnant within the last 6 months or breastfeeding within the last 6 weeks
- •Individuals who smoke or use tobacco products
- •Use of insulin therapy or sulfonylurea medications
- •Allergy to any tree nut
- •Liver or kidney disease
- •Allergy to Dexcom CGM adhesive
结局指标
主要结局
Fasting Glucose Measured Using Continuous Glucose Monitoring
时间窗: 2 weeks
Fasting glucose measures how much glucose (sugar) is in a blood sample after an overnight fast. In this study, fasting glucose was measured by continuous glucose monitoring (interstitial glucose); fasting window identified through review of glucose monitoring data to be 4am-6am.
次要结局
- Inhibitory Control Task (Percent Correct)(2 weeks)
- Glucose Trends(2 weeks)