Effect of Smoking on Postprandial Gastric Emptying, Glucose Tolerance and Secretion of Gut and Pancreatic Hormones
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Postprandial response of glucagon-like peptide-1 (GLP-1)
研究概览
简要总结
The study aims to evaluate the effect of smoking on postprandial responses such as plasma glucose, secretion of gut - and pancreatic hormones and gastric emptying in healthy, heavy smoking men.
详细描述
Epidemiological studies show that active smoking increases the risk of type 2 diabetes in a dose-dependent fashion. Smokers seem to be characterized by central obesity, increased inflammatory markers and oxidative stress, which may lead to insulin resistance and irregularities in glucose metabolism. The current study is a meal test study, in which the aim is to examine a number of variables during a liquid mixed meal test (including gastric emptying, glucose tolerance, gut and pancreatic hormone responses, gall bladder emptying, appetite and food intake) performed in healthy non-smoking subjects and in healthy smokers with or without concomitant cigarette smoking.
The investigators hypothesize that smoking-induced increases in circulating nicotine levels and simultaneous activation of nicotinic receptors in the gastrointestinal tract and in the autonomic nervous system would have detrimental effect on postprandial glucose metabolism and, thus, constitute an important link between smoking and the risk of type 2 diabetes. The current study will help to clarify this hypothesis and improve our general understanding of the association between smoking and gut hormone secretion, gastric emptying and glucose metabolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Both groups
- •Caucasian ethnicity
- •Healthy males
- •Normal haemoglobin
- •Age above 18 years
- •Informed and written consent
- •BMI >20 kg/m2
- •Smokers • Minimum 20 cigarettes pr. day for at least 1 year
- •Non-smokers
- •No smoking on a regular basis
排除标准
- •Both groups
- •Diabetes or prediabetes (fasting plasma glucose levels >6.5 mM or HbA1c >6.0%)
- •First- or second-degree relatives with diabetes
- •Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >2 times normal values) or history of hepatobiliary disorder
- •Gastrointestinal disease, previous intestinal resection, cholecystectomy or any major intra-abdominal surgery
- •Hypo- or hyperphosphataemia
- •Nephropathy (serum creatinine >150 µM and/or albuminuria
- •Treatment with medicine that cannot be paused for 12 hours
- •Hypo- or hypercalcaemia
- •Hypo- and hyperthyroidism
- •Treatment with oral anticoagulants
- •Active or recent malignant disease
- •Any treatment or condition requiring acute or sub-acute medical or surgical intervention
- •Any condition considered incompatible with participation by the investigators
研究组 & 干预措施
Healthy, heavy smoking men
Twelve healthy, male subjects. Intervention: Will undergo two separate, identical test days. One absent smoking, and one with concomitant smoking.
干预措施: Liquid mixed meal (Dietary Supplement)
Healthy, heavy smoking men
Twelve healthy, male subjects. Intervention: Will undergo two separate, identical test days. One absent smoking, and one with concomitant smoking.
干预措施: Skin Biopsy (Other)
Healthy, non-smoking men
Twelve healthy, male subjects. Intervention: Will undergo a liquid mixed meal test and a skin biopsy.
干预措施: Liquid mixed meal (Dietary Supplement)
Healthy, non-smoking men
Twelve healthy, male subjects. Intervention: Will undergo a liquid mixed meal test and a skin biopsy.
干预措施: Skin Biopsy (Other)
结局指标
主要结局
Postprandial response of glucagon-like peptide-1 (GLP-1)
时间窗: -30, -20, -10, 0, 10, 20, 30, 50, 70, 90, 120, 150, 180, 240 minutes (meal tests start at 0 min)
Incremental and total area under the Concentration-Time Curve (AUC 0-240 min)
次要结局
- Postprandial response of Gastrin(-30, -20, -10, 0, 10, 20, 30, 50, 70, 90, 120, 150, 180, 240 minutes (meal tests start at 0 min))
- Gastric emptying(-30, -20, -10, 0, 10, 20, 30, 50, 70, 90, 120, 150, 180, 240 minutes (meal tests start at 0 min)
- GLP-1 receptor expression in the skin(After the 240 minutes)
- Blood Inflammatory and metabolic markers (composite)(-30, -20, -10, 0, 10, 20, 30, 50, 70, 90, 120, 150, 180, 240 minutes (meal tests start at 0 min))
- Gall bladder volume(-30, 20, 40, 80, 240 minutes (meal tests start at 0 min))
- Postprandial response of Glukagon(-30, -20, -10, 0, 10, 20, 30, 50, 70, 90, 120, 150, 180, 240 minutes (meal tests start at 0 min))
- Postprandial response of CCK(-30, -20, -10, 0, 10, 20, 30, 50, 70, 90, 120, 150, 180, 240 minutes (meal tests start at 0 min))
- Postprandial response of GIP(-30, -20, -10, 0, 10, 20, 30, 50, 70, 90, 120, 150, 180, 240 minutes (meal tests start at 0 min))
- Postprandial increment in plasma glucose(-30, -20, -10, 0, 10, 20, 30, 50, 70, 90, 120, 150, 180, 240 minutes (meal tests start at 0 min))
- Postprandial response of insulin(-30, -20, -10, 0, 10, 20, 30, 50, 70, 90, 120, 150, 180, 240 minutes (meal tests start at 0 min))
研究者
Filip Krag Knop
MD, PhD
University Hospital, Gentofte, Copenhagen