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临床试验/NCT02543684
NCT02543684已完成不适用

Post-prandial Glucose and Insulin Levels in Type 2 Diabetes Mellitus Patients After Consumption of Ready-to-eat Mixed Meals

Harokopio University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
serum glucose changes over time

研究概览

简要总结

The aim of the current study was to compare the effects of three ready-to-eat mixed meals, with a high fiber content and low glycemic index, on postprandial glycemic and insulinemic response in patients with Type 2 diabetes mellitus (T2DM).

详细描述

The current study followed a prospective, three-way, cross-over design. Twenty four patients with T2DM consumed three ready-to-eat mixed meals, i.e. "wild greens pie" (meal 1), "chicken burgers with boiled vegetables" (meal 2) and "vegetable moussaka" (meal 3) and an oral glucose load, all providing 50g of carbohydrates. Venous blood was collected at 0, 30, 60, 90 and 120 minutes postprandial for serum glucose and insulin measurements.

The test meals were consumed by study participants between 8:30 to 9:00 am and within 10-15 minutes under a researcher's supervision, following collection of the fasting blood sample. No parallel fluid intake was allowed. The portion size in the case of each one of the three test meals was adjusted to contain 50g of carbohydrates. However, the three test meals were considerably differentiating among them with respect to their content in calories and the remaining macronutrients.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects are eligible if they are 45-75 years of age
  • non-insulin-dependent T2DM with an elapsed time since diagnosis of more than 3 years
  • Body Mass Index (BMI) value higher than 20 kg/m2
  • HbA1c levels of 6.5 to 11%

排除标准

  • insulin-dependent T2DM
  • cardiovascular (i.e. coronary heart disease, stroke etc.)
  • liver and/or renal disease

结局指标

主要结局

serum glucose changes over time

时间窗: fasting baseline glucose at time 0, then 30, 60, 90, and 120 minutes postprandial

serum insulin changes over time

时间窗: fasting baseline insulin at time 0, then 30, 60, 90, and 120 minutes postprandial

次要结局

未报告次要终点

研究者

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

Yannis Manios

Associate Professor

Harokopio University

研究点 (2)

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