Studier af Den Tidlige Måltidsfase i Raske Individer
试验速览
- 阶段
- 不适用
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Plasma GIP concentrations
研究概览
简要总结
To investigate gastrointestinal hormone secretions and nutrient absorption during the early meal phase we will recruit 12 healthy young men. They will be equipped with peripheral intravenous catheters for frequent blood sampling. Participants will be screened and acclimatised to the study situation on visit 1. On visit 2 and 3 participants will in random order ingest an oral glucose solution or a standardised liquid mixed meal over 2-3 min.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 40years
- •Normal Haemoglobin concentration
- •Informed consent
排除标准
- •Diabetes mellitus
- •Family history of diabetes mellitus
- •intestinal disease (for example inflammatory bowel disease or malabsorption)
- •Family history of inflammatory bowel disease
- •Previous intestinal resection (except uncomplicated appendicectomy)
- •Body mass index (BMI) > 25 kg/m2
- •Tobacco use
- •kidney disease (se-creatinine> 130 µM and/or albuminuria)
- •liver disease (ALAT and/or ASAT >2 × above normal range)
- •Heart disease
- •Treatment with drugs
- •History of constipation
- •Conditions with delayed or accelerated gastric emptying
- •Latex or other allergies
- •Bleeding diathesis
研究组 & 干预措施
Oral glucose tolerance test
Intervention: oral glucose tolerance test (75 gram glucose supplemented with 5g 3-OMG and 1g paracetamol) ingested over 2 min.
干预措施: Oral glucose tolerance test (Other)
Liquid mixed meal test
Intervention: Standardised liquid mixed meal (supplemented with 1g paracetamol) ingested over 2min
干预措施: Liquid mixed meal test (Other)
结局指标
主要结局
Plasma GIP concentrations
时间窗: -40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min
Glucose-dependent insulinotropic polypeptide plasma concentrations
次要结局
- Plasma CCK concentrations(-40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min)
- Plasma PP concentrations(-40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min)
- Plasma bile acids(-10, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min)
- Plasma NT concentrations(-40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min)
- Plasma GLP-1 concentrations(-40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min)
- Serum 3-OMG concentrations(-40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min)
- Serum C-peptide and insulin concentrations(-40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min)
- Plasma gastrin concentrations(-40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min)
- Plasma glucagon concentrations(-40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min)
- Plasma acetaminophen(-10, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min)
- Plasma amino acids(-10, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min)
- Serum 3-OMG concentrations(-10, -2, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30)
研究者
Simon Veedfald
Post doc
University of Copenhagen