Does the Bioactive Substance in Coffee, Cafestol, Have Preventive Properties on Type-2-diabetes? Acute and Longer-term Metabolic Effects of Cafestol. (Acute Substudy)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Area under the curve for glucose
研究概览
简要总结
Acute, double-blinded, randomized, cross-over cafestol intervention study with fifteen participants with a large waist circumference participating in three OGTTs.
详细描述
The study is a acute, double-blinded, randomized, controlled intervention in 15 subjects with abdominal obesity at high risk of developing T2D. Initially, a blood sample is obtained (t=-15 min) and at time point 0, the participants will ingest a capsule containing either 6 or 12mg cafestol or placebo. Immediately hereafter an OGTT commences with ingestion of a 75 g glucose solution. In the following 2 hours blood samples are collected at time points 15, 30, 60, 90, 120 and 180 min. The samples will be used for determination of plasma glucose, insulin and cafestol, as well as GLP-1 and GIP. After a one-week washout period, the subject will undergo the same set-up again, however now with the different dosage of cafestol or placebo. The process is repeated for three weeks until every subject has undergone both interventions and the placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •25 < BMI < 40 kg/m2 Waist circumference > 102 cm (men) / 88 cm (women)
排除标准
- •Type 2 diabetes (HbA1c > 48 mmol/mol) or in treatment with antidiabetic drugs
- •Pregnancy
- •Planned pregnancy
- •Breastfeeding
- •Significant comorbidity expected to unable the subject from completing visits
结局指标
主要结局
Area under the curve for glucose
时间窗: -15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution
Area under the curve for glucose during OGTT after ingestion of cafestol or placebo capsule (mmol/L)
次要结局
- Area under the curve for insulin-response(-15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution)
- Area under the curve for cafestol(-15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution)
- Area under the curve for GLP-1 (glucagon-like peptide-1)(-15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution)
- Area under the curve for GIP (Glucose-dependent insulinotropic polypeptide)(-15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution)