Metabolic Effects of the Manipulation of Nutrient Sequence in the Main Meals in Type 2 Diabetic Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from baseline fructosamine after 1 and 2 months of diet
研究概览
简要总结
The investigators aimed at evaluating the metabolic effects of the inversion of the typical Italian sequence of food ingestion at the main meals in type 2 diabetic patients.
详细描述
An intervention group follows a modified diet over a period of two months in which the ingestion of protein and lipid happens before that of carbohydrates. A control group follows a standardized diet in which the ingestion of carbohydrates happens before that of protein and lipid. Both diets contain a reduced intake of high-glycemic index meals, saturated fatty acids, trans fatty acids and alcohol.
On four days separated by one month each other (two before the beginning of the diet and two after 1 month and 2 months of diet) we measure clinical and metabolic parameters (weight, waist and hip circumferences, glucose, glycated hemoglobin, fructosamine, lipid profile) to compare the effects of the two diets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Well-controlled type 2 diabetes
- •HbA1c 48-58 mmol/mol (6.5-7.5%)
- •Treatment with metformin or diet only
- •BMI: < 35 kg/m^2
排除标准
- •Autoimmune diseases, neoplasia, heart, kidney, liver or respiratory failure
- •Pregnancy
- •Bariatric surgery
结局指标
主要结局
Change from baseline fructosamine after 1 and 2 months of diet
时间窗: On four days separated by one month each other (two before the beginning of the diet and two after 1 month and 2 months of diet)
Fructosamine will be measured.
次要结局
- Change from baseline fasting plasma glucose after 1 and 2 months of diet(On four days separated by one month each other (two before the beginning of the diet and two after 1 month and 2 months of diet))
- Change from baseline glycated hemoglobin after 1 and 2 months of diet(On four days separated by one month each other (two before the beginning of the diet and two after 1 month and 2 months of diet))
- Change from baseline weight after 1 and 2 months of diet adipose tissue location(On four days separated by one month each other (two before the beginning of the diet and two after 1 month and 2 months of diet))
- Change from baseline adipose tissue location after 1 and 2 months of diet(On four days separated by one month each other (two before the beginning of the diet and two after 1 month and 2 months of diet))
- Change from baseline lipid profile after 1 and 2 months of diet(On four days separated by one month each other (two before the beginning of the diet and two after 1 month and 2 months of diet))
研究者
Andrea Natali
Professor
Azienda Ospedaliero, Universitaria Pisana