The Effect of a Ketone Drink on Liver Glucose Production in People With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- EGP
研究概览
简要总结
What is the effect of a ketone drink on liver glucose production, and postprandial glycemia, in people with type 2 diabetes.
详细描述
Background: Ketones are molecules that are naturally produced by our body during fasting or diets low in carbohydrates. Ketones can affect how our liver produces and maintains our body's blood sugar levels, which could be important in the management of type 2 diabetes (T2D), where high blood sugar levels are partly because of excess sugar production by the liver.
Objectives: To determine if, and how, a ketone drink can lower blood glucose in people with T2D following a meal.
Methods: Twelve people with T2D will visit our laboratory in the morning on two occasions and ingest a drink containing ketones or placebo on each visit in a random order before ingesting a milkshake style drink containing sugar. Blood samples will then be taken at regular intervals over 4 hours to determine if the ketone drink has lowered blood sugar levels in response to the meal, and if this was due to reduced sugar production by the liver.
Value: This research will provide new knowledge about the regulation of liver blood sugar production in response to ketone ingestion. This may also inform future clinical trials to establish if ketone drinks could be used as a treatment for T2D.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 2 diabetes by a physician, a current HbA1c of 6.5-8.5%, and receiving treatment with lifestyle advice or oral glucose-lowering medications.
- •Non-smoking
- •Blood pressure <160/100 mm/Hg
排除标准
- •Exogenous insulin or SGLT2 inhibitors for type 2 diabetes treatment.
- •Following a low-carbohydrate ketogenic diet, periodic fasting diet, or consuming ketogenic supplements.
- •Other diagnosed chronic metabolic, cardiovascular, respiratory, neurological, or gastrointestinal disease.
- •Blood pressure >160/100 mm/Hg
- •Lactose intolerant
结局指标
主要结局
EGP
时间窗: 6 hours
Endogenous glucose production
次要结局
- Plasma β-OHB(6 hours)
- Postprandial glycemia(4 hours)
- Insulin(6 hours)