Mechanisms Through Which a Small Protein and Lipid Preload Improves Glucose Tolerance in Subjects With Impaired Glucose Homeostasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Plasma glucose response during the Oral Glucose Tolerance Test
研究概览
简要总结
The purpose of this study is:
- to measure the size of the effect on glucose tolerance of a small mixed protein and lipid meal given as a pre-load in individuals with different glucose tolerance status
- to investigate the underlying mechanisms by accurately evaluating beta cell function, insulin sensitivity, insulin clearance and glucose kinetics (oral absorption, endogenous production, rate of utilization) together with gut hormones plasma concentration.
详细描述
As supported by experimental and clinical data, oral carbohydrate tolerance is influenced by the coingestion of nutrients through multiple mechanisms. The ingestion itself, the contact with the gastric mucosa, the arrival into the intestine and the subsequent digestion are known to produce neural reflexes, hormonal responses and plasma substrates gradients which, by modulating gastric emptying, insulin secretion and insulin clearance participate in the regulation of postprandial glycaemia. The size of this effect is influenced by a number of factors: the specific nutrient chemical characteristics (fat vs protein and composition) and their physical properties (solid vs liquid), the timing (pre-load vs coingestion) and finally the individual glucose tolerance status. To our knowledge, the effect on glucose excursions of a combination of protein and fat given before carbohydrate is still unknown and also unknown is the contribution of different mechanisms involved in the control of glucose homeostasis in subjects with different degrees of glucose tolerance.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy, prediabetic or diet-controlled type 2 diabetic patients
- •Subjects ≥ 18 and ≤65 years of age
- •Lean, Overweight or Obese (BMI: 18 to 35 kg/m2)
- •Normal liver and kidney function
- •Normal thyroid function
- •Read and understood the informed consent form and signed it voluntarily
排除标准
- •Liver, heart, kidney, lung, infectious, neurological, psychiatric, immunological or neoplastic diseases.
- •Type 1 or insulin treated diabetes.
- •Pregnancy or lactation
- •Illicit drug abuse or alcoholism
- •Subject treated with insulin or treatment
- •Subjects taking anoretic drugs
- •Subjects on steroid treatment
- •Subjects after bariatric surgery.
结局指标
主要结局
Plasma glucose response during the Oral Glucose Tolerance Test
时间窗: 120 minutes
次要结局
- Plasma Non Esterified Fatty Acids(120 minutes)
- Insulin clearance, estimated by calculating the Insulin secretion/Plasma insulin ratio(120 minutes)
- Beta cells function parameters (glucose sensitivity, rate sensitivity, potentiation factor ratio), calculated by modeling insulin secretion and glucose concentration.(120 minutes)
- Plasma glucagon(120 minutes)
- Insulin secretion, estimated from C-peptide deconvolution(120 minutes)
- Incretin secretion (plasma GLP-1, plasma GIP)(120 minutes)
- Endothelial function assessed as the reactive hyperemia index by an EndoPAT device(fasting, 60 min and 120 min during the control and preload OGTT)
- Insulin sensitivity, estimated from glucose and insulin levels during the Oral Glucose Tolerance Test with the use of Oral Glucose Insulin Sensitivity index(120 minutes)
- Glucose fluxes (intestinal glucose absorption, endogenous glucose production, rate of disappearance of plasma glucose), assessed by modeling glucose tracers enrichments using a standard double tracers technique(120 minutes)
研究者
Andrea Natali
Professor
Azienda Ospedaliero, Universitaria Pisana