NCT05263401已完成不适用
3-hydroxybutyrate as a Meal Primer in Patients With Type 2 Diabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Postprandial P-glucose
研究概览
简要总结
The main objective of this clinical trial is to study the effects of orally administered ketone drinks containing the ketone body, 3-hydroxybutyrate (3-OHB), just before a meal in patients with type 2 diabetes. Moreover the investigators will compare the effects of two different ketone drinks.
The hypothesis is:
3-OHB as a pre-meal may:
- Lower postprandial blood glucose and lipids.
- Mediate release of intestinal hormones and affect gastric emptying.
- Affect appetite and other subjective measures related to food intake.
The effects of 3-OHB as a pre-meal will be investigated by blood samples, isotopic tracers examinations, paracetamol test, questionnaires and meal test.
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 (Participant)
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
- •Type 2 diabetes diagnosis, metformin treated or dietary treated
- •HbA1C < 80 mmol/mol
- •25 < BMI < 35
- •Written consent
排除标准
- •Severe comorbidity
- •Treatment with insulin, GLP-1 analogues, SGLT-2-inhibitors or sulfonylureas
- •Specific diets, e.g. ketogenic diet
- •PI finds the patient not fit (e.g. mental illness, too nervous, unacceptable screening blood tests or other)
结局指标
主要结局
Postprandial P-glucose
时间窗: 3 hours
Incremental area under the curve (iAUC) for P-glucose.
次要结局
- Differences in circulating concentrations of c-peptide(3,5 hours)
- Gastric emptying(3 hours)
- Differences in circulating concentrations of cholecystokinin(3,5 hours)
- Differences in circulating concentrations of Glucagon-like peptide-1 (GLP-1)(3,5 hours)
- Postprandial free fatty acids (FFA)(3 hours)
- Differences in actual hunger(30 minutes)
- Glucose kinetics(3 hours)
- Differences in circulating concentrations of glucagon(3,5 hours)
- Differences in circulating concentrations of Gastric inhibitory polypeptide (GIP)(3,5 hours)
- Differences in circulating concentrations of ghrelin(3,5 hours)
- Differences in circulating concentrations of gastrin(3,5 hours)
- Differences in circulating concentrations of 3-hydroxybutyrate(3,5 hours)
- Lipolysis rate(3 hours)
- Differences in hunger/satiety(4 hours)
- Differences in circulating concentrations of insulin(3,5 hours)
研究者
研究点 (2)
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