A Mediterranean-pattern Meal Increases GLP-1 and Oxyntomodulin More Than an Energy-matched High Fiber Plant-Based Meal in Type 2 Diabetes Patients: A Randomized Clinical Trial Assessment Through the Visual Analogue Scale.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Changes in serum GLP-1 concentration
研究概览
简要总结
The aim of this trial was to assess glycemic control and incretin release in subjects affected by type-2 diabetes, a condition in which GLP-1 release is impaired. It is known that nutrition affects a variety of factors in overall quality of life in diabetes and we hypothesized incretin secretion may improve in acute. As little is known regarding oxyntomodulin secretion in relation to diet, we explored this gut-derived hormone behavior as well.
Hence, the administration of two meals was carried out; these were equal in terms of calories but different for macronutrients composition. Appetite rating was assessed as well through a 100-mm horizontal Visual Analogue Scale, either at fasting and for 4 hours once the meal was completed.
详细描述
Type-2 diabetes (T2D) is a multifactorial metabolic burden whose metabolic features include alterations in GLP-1 secretion and ultimately hunger/satiety circuit derangement. Manipulating the composition of the diet in order to promote GLP-1 secretion may represent a promising lifestyle strategy for obesity and T2D management.
The objective of this study was to assess the post-prandial profile of appetite- regulating hormones and assessing the post-prandial appetite ratings using a Visual Analogue Scale (VAS), as well as measuring the fasting and postprandial glucose/insulin responses in overweight and/or obese, well controlled patients with T2D.
Twelve T2D patients (M:F = 7:5) aged 63.1±8.5 years were enrolled in a randomized, controlled, crossover trial. Subjects consumed on two different days, at one-week interval, an experimental High Fiber Vegetarian meal (HFV) rich in dietary carbohydrate and fiber in comparison with a standard, Mediterranean-like meal (MED). The two meals were isocaloric. Appetite ratings, glucose/insulin and gastrointestinal hormone responses were assessed either at fasting and every 30' until 210' for GLP-1 and Oxyntomodulin and 240' for glucose and insulin after the ingestion of the meal.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type-2 diabetes history of at least 2 years, age above 18 years, body mass index (BMI) between 25 and 35 kg/m2, and drug naïve and/or with metformin treatment.
排除标准
- •clinically significant neurological, endocrinological, or other systemic diseases, as well as those with acute illness and chronic inflammatory or infective disease.
研究组 & 干预措施
HFV meal
A vegetarian meal high in dietary carbohydrate and fiber
干预措施: High-fiber vegetarian meal (Dietary Supplement)
MED meal
A Mediterranean-like meal
干预措施: Mediterranean-like meal (Dietary Supplement)
结局指标
主要结局
Changes in serum GLP-1 concentration
时间窗: 0' (fasting), +30', +60', +90', +120', +150', +180, +210', +240' (minutes)
Changes in serum GLP-1 levels following the ingestion of the two meals
次要结局
- Changes in plasma oxyntomodulin concentration(0' (fasting), +30', +60', +90', +120', +150', +180, +210', +240' (minutes))
- Serum glucose and insulin levels(0' (fasting), +30', +60', +90', +120', +150', +180, +210', +240' (minutes))
- Hunger-satiety scores (millimeters)(0' (fasting), +30', +60', +90', +120', +150', +180, +210', +240' (minutes))
研究者
Antonio Di Mauro
Registered Dietitian Nutritionist
Campus Bio-Medico University