Cross-over, Placebo-controlled, Randomized Trial of β-hydroxybutyrate in Prediabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Rate of change in plasma glucose concentration
研究概览
简要总结
The study aims to investigate changes in blood glucose metabolism after administration of a ketone ester drink.
详细描述
New-onset prediabetes is the most significant risk factor for diabetes. Clinical studies in healthy human volunteers have demonstrated that ketone esters lower blood glucose levels in both fasting and fed state.
Participants will visit the COSMOS clinic on two occasions and will be randomly allocated to receive either the HVMN ketone drink or placebo, in a cross-over design. Blood samples will be collected sequentially every 30 minutes for up to 150 minutes. Blood samples will be assayed for glucose and other markers of glucose metabolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •Individuals over 18 years
- •Individuals diagnosed with prediabetes; defined based on the American Diabetes Association guidelines
- •History of at least one episode of acute pancreatitis
- •Written informed consent
排除标准
- •Individuals who are on a ketogenic diet or consuming nutritional ketone supplements
- •History of cancer or chronic pancreatitis
- •History of bariatric or gastrointestinal surgery
- •Pregnant or breastfeeding women
- •Individuals involved in intensive endurance training or competitive athletics
结局指标
主要结局
Rate of change in plasma glucose concentration
时间窗: Baseline, 30, 60, 90, 120, and 150 minutes
Changes in plasma glucose concentration before and after administration of the intervention/placebo
次要结局
- Rate of change in lipid profile and digestive enzymes(Baseline, 30, 60, 90, 120, and 150 minutes)
- Correlation with physical activity(150 minutes)
- Rate of change in plasma concentration of markers of iron metabolism(Baseline, 30, 60, 90, 120, and 150 minutes)
- Rate of change in plasma concentration of gut and pancreatic hormones(Baseline, 30, 60, 90, 120, and 150 minutes)
- Rate of change in plasma insulin and C-peptide concentrations(Baseline, 30, 60, 90, 120, and 150 minutes)
- Rate of change in plasma concentration of pro-inflammatory cytokines(Baseline, 30, 60, 90, 120, and 150 minutes)
- Correlation with body fat phenotypes(150 minutes)
研究者
Max Petrov
Associate Professor
University of Auckland, New Zealand