Sustained Effects of a Non-glucidic Nutrient Preload on Glucose Tolerance in Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Plasma glucose concentration
研究概览
简要总结
The investigators aimed at evaluating the effects of a small non-glucidic nutrient preload on plasma glucose, insulin, C-peptide, glucagon-like peptide-1, and glucose-dependent insulinotropic polypeptide concentrations after the meal consumption and for 300 min after a 75 g glucose ingestion in diet-controlled type 2 diabetic patients.
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. The effect on 5 h glucose excursions of a combination of protein and fat given before carbohydrate is still unknown.
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
- 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
- 否
入选标准
- •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
- •Subjects taking anoretic drugs
- •Subjects on steroid treatment
- •Subjects after bariatric surgery.
研究组 & 干预措施
Water preload
During the "Water preload" study, each subject consume 500 ml of water 30 minutes before a 75 g glucose ingestion
Nutrient preload
During the "Nutrient preload" study, each subject consume a small mixed meal 30 minutes before a 75 g glucose ingestion. The meal is composed by 50 g of parmesan cheese, one small size boiled egg and 300 ml of water (250 kcal, 23 g protein, 17 g fat and 2 g of carbohydrate).
干预措施: Nutrient preload (Dietary Supplement)
结局指标
主要结局
Plasma glucose concentration
时间窗: 330 minutes
次要结局
- Plasma C-peptide concentration(330 minutes)
- Plasma glucose-dependent insulinotropic polypeptide concentration(330 minutes)
- Plasma Insulin concentration(330 minutes)
- Plasma glucagon-like peptide-1 concentration(330 minutes)
研究者
Andrea Natali
Prof.
Azienda Ospedaliero, Universitaria Pisana