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临床试验/NCT02477761
NCT02477761Unknown不适用

Sustained Effects of a Non-glucidic Nutrient Preload on Glucose Tolerance in Type 2 Diabetes

Azienda Ospedaliero, Universitaria Pisana2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
7
试验地点
2
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

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.

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrea Natali

Prof.

Azienda Ospedaliero, Universitaria Pisana

研究点 (2)

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