Does Co-administration of Lactate to an Oral Glucose Tolerance Test Lower the Glucose Response?
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Difference in integrated glucose concentrations between CTR and LAC following an OGTT
研究概览
简要总结
To investigate whether co-administration of lactate with a glucose load affects postprandial glucose levels/handling, gastrointestinal hormones, gastric emptying, and appetite sensations in individuals with pre-diabetes when compared to placebo.
Hypothesis:
Oral lactate administration improves/lowers glucose excursions following an oral glucose tolerance test (OGTT) by stimulating insulin secretion and delaying glucose absorption.
详细描述
The participants will be instructed to avoid hard-to-moderate physical activity for 48 hours before each of the two trial days. They will be instructed to eat the same diet 72 hours before the two trial days at the screening visit and to register it in MyFood24 which is an electronic foodlog.
Trial days:
The two trial days will be completely alike, besides the interventions consisting of either:
- Placebo in an OGTT (300 mL salt water, NaCl) =CTR, or
- Lactate in an OGTT (300 mL lactate drink = 25 g D/L-lactate bound to Na) =LAC with a stable isotope glucose tracer (D2-glucose) added to each of the interventions to measure glucose uptake. 1500 mg of paracetamol will be added to measure ventricular emptying rate using the acetaminophen test.
An H3-glucose tracer will be continuously infused to measure glucose turnover. Glucose tolerance and absorption together with hepatic glucose production and insulin secretion will be quantified using the oral minimal model.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •>40 years
- •Written and oral consent
- •HbA1c 39-47 mmol/L
排除标准
- •Medicine with an impact on blood glucose and glucose metabolism
- •Newly started medicine (<3 months prior to the inclusion time)
- •Medicine changes (<3 months prior to the inclusion time and planned changes during the trial)
- •Affected screening blood sample as evaluated by PI
- •Hba1c > 47
- •Allergy to paracetamol
- •Doesn't speak or understand Danish.
- •Special diets
结局指标
主要结局
Difference in integrated glucose concentrations between CTR and LAC following an OGTT
时间窗: 0-240 minutes after the OGTT
次要结局
- Difference in insulin secretion(0-240 minutes)
- Difference in glucose absorption(0-240 minutes after the OGTT)
- Difference in ventricular emptying rate(0-240 minutes after the OGTT)
- Difference in integrated GLP-1 concentrations(0-240 minutes after the intervention)
- Difference in insulin sensitivity(0-240 minutes after the OGTT)
- Difference in free fatty acids concentration(0-240 minutes after the OGTT)
- Difference in subjective appetite sensation(0-240 minutes after the intervention)
研究者
Natasa Brkovic Zubanovic
MD PhD student
University of Aarhus